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A.S.P.E.N. Clinical Guidelines: Nutrition Support Therapy During Adult Anticancer Treatment and in Hematopoietic Cell Transplantation

From the ¹ Department of Surgery, Division of Surgical Oncology, Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, Newark, New Jersey, and The Cancer Institute of New Jersey, New Brunswick, New Jersey; the ² Department of Nutrition Sciences, School of Health Related Professions, University of Medicine and Dentistry of New Jersey, Newark, New Jersey, and The Cancer Institute of New Jersey, New Brunswick, New Jersey.

Address correspondence to: Charlene W. Compher, PhD, RD, FADA, LDN, CNSD, University of Pennsylvania School of Nursing, Claire M. Fagin Hall, 418 Curie Boulevard, Philadelphia, PA 19104-4217; e-mail: compherc{at}nursing.upenn.edu.

Nutrition status has an important effect on quality of life and sense of well-being in cancer patients. Malnutrition and weight loss are often contributors to the cause of death in cancer patients.¹

Cancer cachexia is a syndrome characterized by progressive, involuntary weight loss. Clinical features include host tissue wasting, anorexia, skeletal muscle atrophy, anergy, fatigue, anemia, and hypoalbuminemia. Causes of cancer cachexia include anorexia, mechanical factors affecting the gastrointestinal tract related to tumor, side effects of surgery, chemotherapy and/or radiation therapy, alterations in intermediary and energy metabolism, and changes in the host cytokine and hormonal milieu. The cancer cachexia syndrome (CCS), which is observed in approximately 50% of cancer patients, involves heterogeneous physiologic and metabolic derangements resulting in potentially life-threatening malnutrition.² Although often seen in patients with advanced malignancies, CCS may be present in the early stages of tumor growth.

Weight loss in cancer patients is of prognostic significance. For any given tumor type, survival is shorter in patients who experience pretreatment weight loss.^3-5 Furthermore, CCS is a problematic cause of symptom distress in cancer patients.^6,7 Early recognition and intervention to prevent worsening of CCS may afford the best opportunity to prevent its debilitating consequences.

Pharmacologic interventions play only a limited role in overcoming the anorexia and metabolic derangements seen in CCS. Research has focused on the use of nutrition support therapy (NST), bypassing oral intake to circumvent CCS related anorexia. Numerous studies, as summarized by Bozetti, have looked at the effect of nutrition support therapy on nutrition parameters in surgical cancer patients.⁸ Other papers have also examined the use of NST in non-surgical cancer patients.^9,10 Parenteral nutrition (PN) consistently causes weight gain, increases body fat, and improves nitrogen balance. The effect of PN on lean body mass is minimal. The effects of enteral nutrition (EN) on body composition are less consistent; EN usually causes weight gain and improves nitrogen balance. Neither EN nor PN, when administered for 7-49 days, have demonstrably beneficial effects on serum proteins. NST has less of an effect on nutrition indices in cancer patients than in non-cancer patients, probably due to the changes that occur in the metabolism of macronutrient substrates in the presence of cancer.^8,11 Enthusiasm for the use of NST in cancer patients has historically been tempered by concern that provision of nutrients may stimulate tumor growth and metastasis, as observed in animal studies and cell culture.¹² There are few relevant clinical studies.^13-17 Most recently, a study of PN in malnourished gastric cancer patients indicated no significant difference in tumor cell proliferation with administration of PN preoperatively.¹⁸ Absent any overt effects, it is reasonable to ignore this theoretical consideration when contemplating the use of NST in patients.

The purpose of this paper is to examine the literature and develop guidelines only for NST in adult cancer patients (during anticancer treatment and in hematopoietic cell transplantation). Nutrition and cancer prevention or alternative medicine approaches using nutritional supplements in the treatment of cancer is beyond the scope of this paper.

	Methodology

Top Methodology Practice Guidelines and...

 
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is an organization comprised of healthcare professionals representing the disciplines of medicine, nursing, pharmacy, dietetics, and nutrition science. The mission of A.S.P.E.N. is to improve patient care by advancing the science and practice of NST. A.S.P.E.N. vigorously works to support quality patient care, education, and research in the fields of nutrition and metabolic support in all healthcare settings. These clinical guidelines were developed under the guidance of the A.S.P.E.N. Board of Directors. Promotion of safe and effective patient care by nutrition support practitioners is a critical role of the A.S.P.E.N. organization. The A.S.P.E.N. Board of Directors has been publishing clinical guidelines since 1986.^19-21 Starting in 2007, A.S.P.E.N. has been revising these clinical guidelines on an ongoing basis, reviewing about 20% of the chapters each year in order to keep them as current as possible.

These A.S.P.E.N. Clinical Guidelines are based upon general conclusions of health professionals who, in developing such guidelines, have balanced potential benefits to be derived from a particular mode of medical therapy against certain risks inherent with such therapy. However, the professional judgment of the attending health professional is the primary component of quality medical care. Because guidelines cannot account for every variation in circumstances, the practitioners must always exercise professional judgment in their application. These Clinical Guidelines are intended to supplement, but not replace, professional training and judgment.

These clinical guidelines were created in accordance with Institute of Medicine recommendations as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances."²² These clinical guidelines are for use by healthcare professionals who provide nutrition support services and offer clinical advice for managing adult and pediatric (including adolescent) patients in inpatient and outpatient (ambulatory, home, and specialized care) settings. The utility of the clinical guidelines is attested to by the frequent citation of this document in peer-reviewed publications and their frequent use by A.S.P.E.N. members and other healthcare professionals in clinical practice, academia, research, and industry. They guide professional clinical activities, they are helpful as educational tools, and they influence institutional practices and resource allocation.²³

These clinical guidelines are formatted to promote the ability of the end user of the document to understand the strength of the literature used to grade each recommendation. Each guideline recommendation is presented as a clinically applicable statement of care and should help the reader make the best patient care decision. The best available literature was obtained and carefully reviewed. Chapter author(s) completed a thorough literature review using MEDLINE®, the Cochrane Central Registry of Controlled Trials, the Cochrane Database of Systematic Reviews, and other appropriate reference sources. This paper includes older as well as current research related to the use of NST in individuals with cancer. Dates prior to 1990 were not excluded from the analyses, as there are no obvious trends over time to suggest that more modern practice has had an impact on outcome. These results of the literature search and review formed the basis of an evidence-based approach to the clinical guidelines. Chapter editors work with the authors to ensure compliance with the author's directives regarding content and format. Then the initial draft is reviewed internally to ensure consistency with the other A.S.P.E.N. Guidelines and Standards, and externally reviewed (by experts in the field within our organization and/or outside of our organization) for appropriateness of content. The final draft is reviewed and approved by the A.S.P.E.N. Board of Directors.

The system used to categorize the level of evidence for each study or article used in the rationale of the guideline statement and to grade the guideline recommendation is outlined in Table 1.²⁴

The grade of a guideline is based on the levels of evidence of the studies used to support the guideline. A randomized controlled trial (RCT), especially one that is double blind in design, is considered to be the strongest level of evidence to support decisions regarding a therapeutic intervention in clinical medicine.²⁵ A systematic review (SR) is a specialized type of literature review that analyzes the results of several RCTs. A high-quality SR usually begins with a clinical question and a protocol that addresses the methodology to answer this question. These methods usually state how the literature is identified and assessed for quality, what data are extracted, how they are analyzed, and whether there were any deviations from the protocol during the course of the study. In most instances, meta-analysis (MA), a mathematical tool to combine data from several sources, is used to analyze the data. However, not all SRs use MA. SR is considered among the most important level of evidence in the field of Evidence-Based Medicine. A level of I, the highest level, will be given to large RCTs where results are clear and the risk of alpha and beta error is low (well-powered). A level of II will be given to RCTs that include a relatively low number of patients or are at moderate-to-high risk for alpha and beta error (under-powered). A level of III is given to cohort studies with contemporaneous controls, while cohort studies with historic controls will receive a level of IV. Case series, uncontrolled studies, and articles based on expert opinion alone will receive a level of V.

	Practice Guidelines and Rationales

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Table 2 provides the entire set of guidelines recommendations for NST during adult anticancer treatment and in hematopoietic cell transplantation.

A. Nutrition Support Therapy During Anticancer Treatment

1. Patients with cancer are nutritionally-at-risk and should undergo nutrition screening to identify those who require formal nutrition assessment with development of a nutrition care plan. (Grade: D)

Rationale: There is clear evidence that nutrition screening with appropriate screening tools will identify cancer patients who are malnourished.^26-32 Among the developed screening tools are the patient generated subjective global assessment (PGSGA),^27,28 the subjective global assessment (SGA),^26,27,30,31 and the nutrition risk index (NRI).³⁰ They all have validated specificity and sensitivity in cancer patients, have been the subjects of prospective clinical trials, and share an emphasis on clinical data. Given the effectiveness of the instruments in detecting malnutrition in cancer patients, it makes sense to utilize these instruments to identify malnutrition and risk of malnutrition.

Although there is limited evidence available specifically examining the efficacy of nutrition screening in improving clinical outcomes in cancer patients, the detrimental effects of weight loss on outcomes has been demonstrated.^3,33,34 In addition, the benefits of nutrition counseling in cancer patients have been reported.^35-38 It seems logical that a formal nutrition screening should be performed in every cancer patient to identify individuals at-risk who require a formal nutrition assessment in an attempt to minimize weight changes and identify individuals who may benefit from further nutrition intervention. Clinical trials are needed to assess the impact of nutrition screening on outcomes in cancer patients.

See Table A1.

2. Nutrition support therapy should not be used routinely in patients undergoing major cancer operations. (Grade: A)

Rationale: Many studies have investigated the use of NST in patients undergoing major cancer operations, such as resections in the thoracic and abdominal cavities. The use of PN in surgical patients has been studied in prospective, randomized, controlled trials in comparison to standard oral diet (SOD) and EN. Likewise, EN has been examined in relation to SOD.

The majority of PN vs SOD^41-51 studies find no differences in morbidity⁴¹ or mortality,^41,48 or even increased morbidity^46,47,50 or mortality,⁴² with the use of PN. Those studies that did indicate benefits from PN tended to include heterogeneous populations^43,45 that consisted of both malnourished and well nourished patients. Unfortu nately, some studies reporting benefits also had faulty study designs.⁴⁴ These studies suggest that PN may be beneficial when used perioperatively in severely malnourished patients; however, PN is not beneficial when used routinely in all patients.

Comparisons of PN to EN^52-63 also indicate few differences in morbidity^53-56,58 or mortality^52-54,56 between the modalities. However, EN is favored to preserve gut integrity^56,60,64 and immune markers^55,57,61,63 and to simplify glycemic management.^56,59

Similarly, the majority of studies comparing EN to SOD^65-69 indicate no benefit of EN over SOD with respect to morbidity^65,66,68,69 and mortality.^65,66,68,69

The evidence does not indicate improved outcomes with routine use of NST in all patients undergoing major cancer operations.

See Table A2.

3. Perioperative nutrition support therapy may be beneficial in moderately or severely malnourished patients if administered for 7-14 days preoperatively, but the potential benefits of nutrition support must be weighed against the potential risks of the nutrition support therapy itself and of delaying the operation. (Grade: A)

Rationale: Studies specifically assessing the use of perioperative NST in moderately or severely malnourished cancer patients, as assessed by the SGA, the PGSGA, or the NRI,^{41,42,45,46,49,51,52,57} indicate a benefit in morbidity^{8,45,46,51,52,57} and mortality.^8,51,57 These studies began administration of NST 7-14 days preoperatively.^46,49,51

See Table A3.

4. Nutrition support therapy should not be used routinely as an adjunct to chemotherapy. (Grade: B)

Rationale: Malnutrition can occur in cancer patients starting or receiving chemotherapy as a result of the tumor-induced abnormalities or due to treatment-induced toxicity. Several studies have examined the use of NST during chemotherapy to prevent the development of malnutrition or to mitigate its consequences.^64,70-82 When used in this fashion, NST does not reduce chemotherapy-related toxicity^{70-75,77,78,80,81} and does not improve tumor response^{70-75,77,78,80,81} or patient survival.^70,71,75 All studies were limited by small sample size. Because of an associated increase in the risk of infection with the use of PN in this setting, routine adjunctive use in well-nourished patients receiving chemotherapy is actually deleterious.

See Table A4.

5. Nutrition support therapy should not be used routinely in patients undergoing head and neck, abdominal, or pelvic irradiation. (Grade: B)

Rationale: Few clinical trials investigating the routine use of NST as an adjunct to radiation therapy in cancer patients have been reported.^83-86 One study of upper GI cancer patients indicated less weight loss and fewer treatment interruptions in patients who received EN prior to radiation therapy (XRT).⁸³ Two studies in head and neck cancer patients failed to demonstrate reduced weight loss⁸⁴; furthermore, worse survival⁸⁵ was observed in patients who received PN and/or EN before XRT. The role for routine EN, PN, or oral supplement use during head and neck, abdominal, or pelvic irradiation is not clear. The use of NST should be reserved for those patients who are unable to eat as a result of tumor or treatment related side-effects who are becoming progressively malnourished.

See Table A5.

6. Nutrition support therapy is appropriate in patients receiving active anticancer treatment who are malnourished and who are anticipated to be unable to ingest and/or absorb adequate nutrients for a prolonged period of time. (Grade: B)

Rationale: NST is appropriate in patients receiving active anticancer treatment who are malnourished and who will be unable to absorb adequate nutrients for a prolonged period of time to minimize risk of poor outcomes associated with malnutrition. Seven to fourteen days seems an appropriate definition of "prolonged period of time"; this time period is referred to in many studies, although there are no well designed studies that specifically address this issue. Although no survival benefit with NST intervention has been reported, multiple studies have reported improvements in weight^81,83 and nitrogen balance.^81,82 The strength of this guideline is tempered by the fact that the best and largest RCT is limited to a head and neck population receiving radiation.⁸⁵

See Table A6.

7. The palliative use of nutrition support therapy in terminally ill cancer patients is rarely indicated. (Grade: B)

Rationale: The palliative use of NST in cancer patients is rarely appropriate, although this issue remains controversial and is emotionally charged. The decision to initiate NST in patients with advanced cancer must include consideration of the patient's and family's wishes, potential risks and benefits, and the patient's estimated survival. The primary objective for initiating NST in advanced cancer patients is to conserve or restore the best possible quality of life and to control any nutrition related symptoms that cause distress.⁸⁸ There are limited data on the use of PN in palliative care.^8,89-96 Although the adverse events caused by PN may actually worsen quality of life and overall palliative care of some patients, home PN may lengthen survival^89,92 and improve quality of life in carefully selected patients.^90,91,94 Examples of patients who have demonstrated a favorable response to PN include patients with a good performance status, such as Karnofsky score >50, those with inoperable bowel obstruction, those with minimal symptoms from disease involving major organs such as brain, liver, and lungs, and those with indolent disease progression.^88,97

If patients are to benefit from this complex, intrusive, and expensive therapy they (1) must be physically and emotionally capable of participating in their own care; (2) should have an estimated life expectancy of >40-60 days; (3) require strong social and financial support at home, including a dedicated in-home lay care provider; and (4) must have failed trials of less invasive medical therapies such as appetite stimulants and enteral feedings.⁹⁸ Those patients with a life expectancy of <40 days may be palliated with home intravenous fluid therapy, although this is also controversial.^88,90,97,99

See Table A7.

8. -3 Fatty acid supplementation may help stabilize weight in cancer patients on oral diets experiencing progressive, unintentional weight loss. (Grade: B)

Rationale: -3 Fatty acids favor production of prostaglandins in the 3-series (PGE3) and leukotrienes in the 5-series (which are associated with improved immunocompetence and reduced inflammatory responses) and reduce levels of the PGE2 and leukotrienes in the 4-series (immunosuppressive and proinflammatory) in comparison with -6 fatty acids.^100,101 -3 Fatty acids have been supplemented enterally in pill form^102-106 and in liquid nutritional supplements.^107-117 In addition to the effects of -3 fatty acids on prostaglandin synthesis and COX-2 inhibition (indomethicin 50 mg twice a day), they also seem to be effective in reducing proinflammatory cytokines in CCS.^{102,103,108,110,114} Early studies of -3 fatty acids were performed in pancreatic cancer patients^{102,105,108-112,116}; more recent studies have looked at other cancer types.^{103,104,106,107,113,115,117} Enteral -3 fatty acids appear to stabilize weight^{109,110,113-115} or decrease the rate of weight loss^102,105 in cancer patients, although this appears to occur with little or no increase in lean body mass.^{102,105,106,111,112,116} A target dose of 2 g of eicosapentanoic acid daily appears appropriate. This may be administered as commercially available -3 enriched liquid nutritional supplements or as over-the-counter -3 fatty acid supplements (available in most pharmacies). Because these supplements are not commonly covered by health insurance, the cost of this intervention should be considered.

See Table A8.

View this table: [in this window] [in a new window]   Table A8. -3 Fatty Acid in Weight Maintenance

9. Patients should not use therapeutic diets to treat cancer. (Grade: E)

Rationale: Peer-reviewed literature on the efficacy or safety of therapeutic diets for treatment of cancer is limited.^118-120 Studies of the "macrobiotic diet" (very low-fat, moderately high-fiber, and moderately reduced calories),¹¹⁸ the Gonzalez regimen (large doses of orally ingested pancreatic enzymes, nutritional supplements, "detoxification" procedures, and an organic diet),¹¹⁹ and the Gerson diet (lactovegetarian; low sodium, fat, and protein; high potassium, hourly raw vegetable/fruit juices; and coffee enemas)¹²⁰ are methodologically uninterpretable and poorly characterize both the patients studied and the regimens administered. There are no valid published data at this time to support the safety or efficacy of these regimens for the treatment of cancer. As such, they may in fact be harmful, given their dramatic deviations from recommended nutrition intakes. Therefore, these diets should be thought of as sham diets promoted to unsuspecting patients and clinicians until data from methodologically sound studies suggest otherwise.

10. Immune enhancing enteral formulas containing mixtures of arginine, nucleic acids, and essential fatty acids may be beneficial in malnourished patients undergoing major cancer operations. (Grade: A)

Rationale: Use of specific substances for effects beyond their nutrition role may be referred to as nutritional pharmacology. Four nutrients especially have been the subject of recent research: glutamine, arginine, nucleic acids, and essential fatty acids. Clinical trials evaluating nutritional pharmacologic interventions in perioperative cancer patients using an enteral formula containing a mixture of "immune enhancing" substrates including arginine, RNA, and -3 fatty acids^68,121-129 have reported improved immune parameters^123-125 and clinical outcomes.^122-129 Unfortunately, the methodological diversity of these studies limits the ability to determine the best timing for initiation of immune enhancing EN. The U.S. Summit on Immune-Enhancing Enteral Therapy produced consensus recommendations regarding the use of these formulas in surgical patients.¹³⁰ It was recommended that individuals undergoing gastrointestinal or major head and neck surgery in whom there is preexisting malnutrition would benefit from 5-7 days preoperative supplementation.¹³⁰ Fewer studies have examined supplementation with single nutrients.^131-133 The data on the use of arginine- or glutamine-supplemented formulas are too limited at this time to make recommendations on the use of these formulations. However, based on the studies of combined use of arginine, RNA, and -3 fatty acids with clinical endpoints, EN supplemented with these nutrients may be beneficial in malnourished patients undergoing major cancer operations.

See Table A10.

B. Nutrition Support Therapy in Hematopoietic Cell Transplantation
Hematopoietic cell transplantation (HCT) refers to an array of therapies whose short- and long-term outcomes are affected by diagnosis, disease stage, transplant type (autologous, family related allogeneic, unrelated allogeneic), degree of donor histocompatibility, preparative regimen (myeloablative vs non-myeloablative), stem cell source (bone marrow, peripheral blood, placental cord blood), age, prior therapy, and nutrition status.^134,135 Conventional HCT involves high-dose chemotherapy with or without irradiation to eradicate tumor in patients with malignancy, with subsequent autologous reconstitution of bone marrow with previously harvested cells. In allograft recipients, the patient's own immune system is completely ablated to prevent graft rejection. Such marrow ablative regimens are among the most intensive therapies used in oncology. Lower intensity cytoreduction (partial ablation) may alternatively be used to establish a mixed chimera, with preservation of host T-cell–mediated immunity.¹³⁶ Gastrointestinal tract or liver complications are almost always the dose-limiting toxicities for these therapies.¹³⁷ The disruption of the mucosal barrier contributes to the development of infections during the period of ablation-induced neutropenia that may last as long as 6 weeks. As a result of mucositis, intense diarrhea, and systemic effects of chemotherapy, patients experience a prolonged period of minimal oral intake. This may last well beyond the milestone of stem cell engraftment owing to the delayed effects of cytoreductive therapy on appetite, taste, salivary function, gastric emptying, and intestinal function.¹³⁸

Especially problematic in recipients of allografts is donor T-lymphocyte–mediated graft-versus-host disease (GVHD). Acute GVHD occurs in the first few months posttransplant and targets the skin, liver, and gastrointestinal tract. A chronic form resembling collagen-like immune disorders may develop several months to years posttransplant and involve single or multiple organs (skin, liver, oral mucosa, eyes, musculoskeletal system, lung, esophagus, and vagina). Moderate to severe GVHD and the multi-drug regimens used in its prevention and treatment result in profound and prolonged immunosuppression. Despite advances in management, GVHD remains a significant problem because of the expanding use of unrelated and partially histocompatible related donors. Patients frequently have elevated nutrient requirements and altered carbohydrate, fat, and protein metabolism. They may also experience difficulty eating for a variety of reasons dependent on organ involvement and frequently require modified diets, oral supplements, or NST to prevent malnutrition.^137,139 Significantly higher mortality occurs in underweight patients undergoing HCT, even among those with only mild deficits.^135,140 Obesity also appears to have a negative influence on outcome.^140-142 The role, if any, for pretransplant intervention has not been investigated.

1. All patients undergoing hematopoietic cell transplantation with myeloablative conditioning regimens are at nutrition risk and should undergo nutrition screening to identify those who require formal nutrition assessment with development of a nutrition care plan. (Grade: D)

Rationale: HCT patients are predisposed to developing malnutrition because of their underlying disease, the conditioning regimen, and other treatment-related toxicities.^139,143-145 Increase in morbidity^139,143,145 and mortality¹⁴⁵ has been reported in malnourished patients receiving HCT. Alterations in nutrition status persist long after transplantation, with as many of 50% of patients not returning to pre-transplant weight at 1 year.¹⁴⁴

Although evidence characterizing the clinical impact of nutrition in HCT patients is limited, appropriate screening of HCT patients should minimize risk of the detrimental effects of weight loss in patients with cancer including those undergoing HCT. Clinical trials are needed to assess the impact of nutrition screening on outcomes in cancer patients.

See Table B1.

2. Nutrition support therapy is appropriate in patients undergoing hematopoietic cell transplantation who are malnourished and who are anticipated to be unable to ingest and/or absorb adequate nutrients for a prolonged period of time (see Guideline 6 Rationale for discussion of "prolonged period of time"). When parenteral nutrition is used, it should be discontinued as soon as toxicities have resolved after stem cell engraftment. (Grade: B)

Rationale: NST is appropriate in patients undergoing HCT who are malnourished and who will be unable to absorb adequate nutrients for a prolonged period of time to minimize risk of poor outcomes associated with malnutrition. Seven to 14 days seems an appropriate definition of "prolonged period of time"; this time period is referred to in many studies, although there are no well designed studies that specifically address this issue.

Evaluating the effect of PN and EN in HCT patients is difficult because of patient and treatment heterogeneity. The risks and benefits of using PN in HCT have been assessed comparing PN vs SOD^146-149 or EN^150-152 vs PN vs intravenous fluids (IVF) alone.^153-155

Studies of PN vs SOD or EN demonstrate increased morbidity,¹⁴⁶ more diarrhea,¹⁵⁰ more hyperglycemia,^151,152 and delayed time to engraftment^149,152 but less weight loss^146,147 and less loss of body fat¹⁴⁸ with PN. There appear to be no differences in incidence or severity of GVHD.¹⁴⁶

Comparison of PN to IVF^153-155 indicate earlier resumption of oral intake with IVF¹⁵³ but no difference in morbidity.¹⁵⁵ A study of children and adults reported a positive effect of PN on mortality compared to those who received IVF in patients who received allogeneic transplants, but not autologous transplants.¹⁵⁵ There was no difference in GVHD between groups; however, the allogeneic transplant patients had higher incidence of bacteremia which occurred sooner with PN. These results have not been repeated.

The effects of PN composition on outcome has been investigated.^156,157 Limited results indicate no benefit to use of "high nitrogen" PN.¹⁵⁶ There may be a decrease in the incidence of GVHD with the use of lipid-based PN (80% of non-protein calories from fat) compared to a glucose-based (100% of non-protein calories from dextrose) formula.¹⁵⁷

If PN is used in HCT, it should be discontinued after stem cell engraftment when adequate EN or oral intake is feasible.

See Table B2.

3. Enteral nutrition should be used in patients with a functioning gastrointestinal tract in whom oral intake is inadequate to meet nutrition requirements. (Grade: C)

Rationale: Use of peri-transplant EN after conditioning regimens has been investigated.^{150-152,158-160} Studies have included small numbers of patients receiving enteral feeding or oral intake compared to PN alone or in combination of EN or PN, which makes evaluation of clinical outcomes difficult. In general, less diarrhea and less hyperglycemia (defined as blood glucose >110-150 mg/dL) have been reported in patients receiving EN.^151,152,158 The effect on time to engraftment is not clear.^149,152 EN may also be associated with a decreased risk of severe GVHD.¹⁶⁰

The challenges of establishing safe enteral access after marrow-ablative preparative regimens are formidable owing to coagulopathy, the risk of aspiration pneumonia, sinusitis, diarrhea, ileus and/or abdominal pain, delayed gastric emptying, and vomiting.¹⁶¹ However, safe enteral tube feeding has been reported in HCT patients during the peri-transplant period. Once neutrophil and platelet counts have returned and gastrointestinal tissues have healed, EN is safe as a transition step from PN to oral diet or when NST is indicated for late complications such as GVHD.

See Table B3.

4. Pharmacologic doses of parenteral glutamine may benefit patients undergoing hematopoietic cell transplantation.* (Grade: C)

*Note: parenteral glutamine is not available by the usual U.S. Food and Drug Administration (FDA)-approved manufacturer process but rather as a prescription prepared by a compounding pharmacy in the U.S. Glutamine appears on the FDA List of Bulk Drug Substances That May Be Used in Pharmacy Compounding. (See Federal Register 1999;64:996-1003).

Rationale: The roles of both enteral^162-165 and parenteral^165-172 glutamine (GLN) supplementation in HCT have been examined. Studies assessing the impact of enterally administered GLN indicate no reduction in morbidity^162-165 or mortality.^163-165 Parenterally administered GLN is associated with improved nitrogen balance,¹⁷² shorter length of hospital stay,^171,172 and decreased morbidity.^167,171-173 One small, complex study of prophylactic PN vs PN initiated after a decrease in oral intake indicated that patients who received supplemental GLN had a shorter disease-free survival, with no impact on morbidity or overall survival.¹⁷⁰ The results indicated a decreased incidence of severe mucositis in patients receiving supplemental GLN parenterally. These results were not seen with orally supplemented GLN. A recent Cochrane review concluded that GLN in PN may not be associated with reduced length of hospital stay, but a benefit of fewer bloodstream infections remains.¹⁷³ Providing parenteral GLN remains complicated by a lack of commercially available intravenous formulation. More research is needed to determine appropriate dose and timing.

See Table B4.

5. Patients should receive dietary counseling regarding foods which may pose infectious risks and safe food handling during the period of neutropenia. (Grade: C)

Rationale: Although the effect of low-microbial or sterile diets on risk of infection is unknown, neutropenic HCT patients should avoid foods associated with an increased infectious risk. Several studies have examined the role of diet and infectious risk in combination with other interventions such as isolator units and laminar airflow rooms.^174-180 It is hard to make comparisons between these groups because the dietary restrictions were not adequately described. One study suggested a reduced incidence of infection in patients who received a sterile diet¹⁷⁷; however, a subsequent study indicated no difference.¹⁷⁶ A descriptive survey by Smith et al found that 78% (n = 120) of Association of Community Cancer Centers (ACCC) member institutions utilized low microbial diets. There were wide variations in the white blood cell and neutrophil counts used to trigger ordering of low microbial diets.¹⁸¹ A more recent small RCT that compared neutropenic diet to the FDA's food safety guidelines indicated no additional benefit of the neutropenic diet in pediatric patients receiving myeloablative chemotherapy.¹⁸² This was also seen in a study of cooked and noncooked diets in patients undergoing remission induction therapy for acute myeloid leukemia.¹⁸³ Overall, there is a need for more systematic research on this topic. Until this is available, it seems prudent to continue to provide dietary restrictions on high-risk foods during the period of neutropenia, while paying attention to the palatability of food choices in these anorectic patients.

See Table B5.

6. Nutrition support therapy is appropriate for patients undergoing hematopoietic cell transplantation who develop moderate to severe graft-vs-host disease accompanied by poor oral intake and/or significant malabsorption. (Grade: C)

Rationale: Limited data are available on the impact of NST on the incidence of GVHD.^{146,155,157,160,162,184} PN does not seem to decrease the incidence of GVHD in individuals undergoing HCT.^146,155 In fact, high dextrose (100% non-protein calories) PN has been associated with an increased incidence of GVHD.¹⁵⁷ Incidence of GVHD appears to decrease with increased protein intake in patients consuming SOD¹⁸⁴ or EN.¹⁶⁰ Once GVHD occurs, oral nutrition can become increasingly challenging. Although there are no data on the impact of NST on the resolution of GVHD, it seems logical that NST should be used to maintain/improve nutrition status during prolonged nutrition compromise resulting from GVHD.

See Table B6.

Top Methodology Practice Guidelines and...

 
Financial disclosure: none declared.

The authors wish to acknowledge the input of Carol Rollins, MS, RD, PharmD, CNSD, BCNSP; Patricia A Worthington, MSN, RN, CNSN; and Charlene Compher, PhD, RD, FADA, CNSD, in the development of these Clinical Guidelines.

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Journal of Parenteral and Enteral Nutrition, Vol. 33, No. 5, 472-500 (2009)
DOI: 10.1177/0148607109341804


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