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W620730509 abstract "Nutrition & DieteticsVolume 65, Issue s1 p. 1-20 Free Access Evidence based practice guidelines for the nutritional management of patients receiving radiation therapy First published: 13 February 2008 https://doi.org/10.1111/j.1747-0080.2008.00252.xCitations: 10AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat FOREWORD These guidelines were developed following the publication of the Evidence based guidelines for the nutritional management of cancer cachexia. In workshops conducted around the country, many dietitians identified the need for guidelines on the management of malnutrition occurring with anticancer treatments. We have focused on radiation therapy treatment (patients may also be undergoing synchronous or sequential chemotherapy) for these guidelines as there have been several recent randomised controlled trials (RCTs) which have evaluated nutrition intervention. Studies evaluating the nutritional management of patients receiving chemotherapy alone are not included as there are no recently published RCTs. The older evidence does not demonstrate benefits with respect to survival or tumour response; however, the ability to draw conclusions is difficult due to study design limitations.1 When published nutrition RCTs in patients receiving chemotherapy become available these can be included in future reviews of these guidelines, and hence they will become broader guidelines for the nutritional management of patients receiving radiation therapy and/or chemotherapy treatment. NHMRC levels of evidence (1999) Level I Evidence obtained from a systematic review of all relevant randomised controlled trials Level II Evidence obtained from at least one properly designed randomised controlled trial Level III-1 Evidence obtained from well-designed pseudo-randomised controlled trials (alternate allocation or some other method) Level III-2 Evidence obtained from comparative studies with concurrent control and allocation not randomised (cohort studies), case–control studies, or interrupted time series with a control group Level III-3 Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel group Level IV Evidence obtained from case studies, either post-test or pre- and post-test. NHMRC grades of recommendation (2005) Level A Body of evidence can be trusted to guide practice Level B Body of evidence can be trusted to guide practice in most situations Level C Body of evidence provides some support for recommendation(s) but care should be taken in its application Level D Body of evidence is weak and recommendation(s) must be applied with caution. EXECUTIVE SUMMARY A Steering Committee of dietitians with clinical and research expertise has developed Evidence based practice guidelines for the nutritional management of patients receiving radiation therapy. The purpose of these guidelines is to provide dietitians in Australia and New Zealand with a summary of evidence based clinical questions related to the dietetic management of adult patients with cancer undergoing radiation therapy. Key clinical questions have been developed for the stages of the Nutrition Care Process as described below:2 • Appropriate access to nutrition care (nutrition screening; nutrition assessment; collection of evidence) • Quality nutrition care—nutrition diagnosis, nutrition intervention (establishing goals; prescription and implementation) • Nutrition monitoring and evaluation—outcomes (measuring and evaluating outcomes). This best available evidence is presented and used as a basis for providing recommendations about clinical practice. The strength of the evidence was assessed using the level of evidence rating system recommended by the NHMRC publication, A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines (1999).3 These guidelines have undergone peer and expert review in the form of several workshops to Australian and New Zealand dietitians and targeted stakeholder and expert evaluation. These guidelines have been presented to a multidisciplinary audience including oncologists, surgeons, nurses, pharmacists, radiation therapists and speech pathologists attending the Australia and New Zealand Head and Neck Society and Clinical Oncological Society of Australia conferences in 2007. These guidelines have been endorsed by the Dietitians Association of Australia (DAA) and are available on the DAA website. These guidelines provide the best available evidence and can be used as a framework to aid decision-making. However, they should be followed subject to the health professionals' judgement in each individual case and ideally used as part of a multidisciplinary approach. The Evidence based practice guidelines for the nutritional management of patients receiving radiation therapy is intended to be reviewed every 3 years by the Steering Committee to ensure they remain current. The next review date is 2010. Subsequent reviews will include any published nutrition randomised controlled trials conducted in patients receiving chemotherapy resulting in a broadening of the guidelines to cover the nutritional management of patients receiving radiation therapy and/or chemotherapy. There may be the option to combine these guidelines with the cachexia guidelines to result in one broad set of nutrition and cancer guidelines. These guidelines will be available on the DAA website (http://www.daa.asn.au), in the Guidelines section, and will include extra information, e.g. full methodology, and will include future updates to the guidelines. EVIDENCE BASED PRACTICE GUIDELINE FRAMEWORKSUMMARY OF EVIDENCE BASED RECOMMENDATIONS The clinical questions and evidence based recommendations are listed under headings based on the nutrition care process. Full details of the evidence based statements are listed on pages S10–S15. Appropriate access to care Nutrition screening Clinical question How should patients be identified for referral to the dietitian (and/or nutrition support) in order to maximise nutrition intervention opportunities? Evidence based recommendations All patients receiving radiation therapy to the gastrointestinal tract (GIT) or head and neck area should be referred to the dietitian (and/or nutrition support). NHMRC grade of recommendation: B Patients receiving radiation therapy to the oesophageal or head and neck area should be referred prior to commencement of radiation therapy for consideration of a prophylactic gastrostomy/jejunostomy. Other patients at nutritional risk can be identified using a nutrition screening tool which has been validated in patients receiving radiation therapy (e.g. Malnutrition Screening Tool).5 NHMRC grade of recommendation: C Nutrition assessment Clinical question How should nutritional status be assessed? Evidence based recommendation Validated nutrition assessment tools (e.g. scored Patient Generated-Subjective Global Assessment (PG-SGA)6 or Subjective Global Assessment (SGA)7 should be used to assess the nutritional status of patients receiving radiation therapy. NHMRC grade of recommendation: B Quality nutrition care Nutrition intervention Clinical question What are the goals of nutrition intervention for patients receiving radiation therapy? Evidence based recommendation Aim to minimise weight loss and maintain quality of life and symptom management in patients receiving radiation therapy. NHMRC grade of recommendation: C Clinical question What is the nutrition prescription to achieve these goals? Evidence based recommendation Aim for energy and protein intakes of at least 125 kJ/kg/day and 1.2 g protein/kg/day in patients receiving radiation therapy. Patients should have their weight and food/energy intake monitored regularly to determine whether their energy requirements are being met. NHMRC grade of recommendation: C Clinical question What are effective methods of implementation to ensure positive outcomes? Evidence based recommendations Dietary counselling and/or supplements are effective methods of nutrition intervention, and frequent (at least fortnightly) dietitian contact improves outcomes in patients receiving radiation therapy. NHMRC grade of recommendation: A Currently there is no clear evidence to identify patients who would benefit from a prophylactic gastrostomy/jejunostomy. However, there is some evidence to support that certain oesophageal and head and neck cancer patients and/or those undergoing chemo-radiation would benefit from a prophylactic gastrostomy/jejunostomy. Identify patients who may require a prophylactic gastrostomy/jejunostomy and advocate for placement prior to treatment. For patients not tolerating adequate intake orally, nutrition support using tube feeding can help minimise weight loss. NHMRC grade of recommendation: C Clinical question Is nutrition intervention beneficial in preventing or treating radiation enteritis? Evidence based recommendations Currently there is no clear evidence for the management of radiation enteritis due to the small number of studies and varied study designs. There is some evidence, however, supporting individualised dietary counselling. Nutrition monitoring and evaluation Clinical question Does nutrition intervention improve intermediate (dietary and nutritional) outcomes in patients receiving radiation therapy? Evidence based recommendations Regular nutrition intervention (dietary counselling and/or supplements) improves energy and protein intake and nutritional status during radiation therapy. NHMRC grade of recommendation: A Nasogastric tube (NGT) and percutaneous endoscopic gastrostomy (PEG) feeding are effective in achieving higher protein and energy intakes and weight maintenance in head and neck cancer patients undergoing radiation therapy compared with oral intake alone. The method of feeding (NGT vs PEG) should therefore reflect the anticipated length of feeding required. NHMRC grade of recommendation: B Clinical question Does nutrition intervention improve cost outcomes in patients receiving radiation therapy? Evidence based recommendation Nutrition intervention reduces treatment breaks and unplanned hospital admissions resulting in decreased costs compared with usual care. NHMRC grade of recommendation: C Clinical question Does nutrition intervention improve patient-centred outcomes in patients receiving radiation therapy? Evidence based recommendations Nutrition intervention (dietary counselling and/or supplements) during and post radiation therapy improves patient-centred outcomes (quality of life, physical function and patient satisfaction). NHMRC grade of recommendation: B Nutrition support via gastrostomy/jejunostomy for head and neck cancer patients during radiation therapy improves patient-centred outcomes (quality of life) compared with oral diet alone. NHMRC grade of recommendation: C Clinical question What nutrition follow up should patients undergoing radiation therapy receive? Evidence based recommendations In the short term, nutrition follow up is recommended for approximately six weeks post radiation therapy. In the long term, a minimum of six-month follow up is recommended for patients who require alternative feeding during radiation therapy. Oral rehabilitation and preventing gastrostomy/jejunostomy dependency, as well as managing late side-effects impacting on nutritional status, should be considered. NHMRC grade of recommendation: D 1: INTRODUCTION AND BACKGROUND 1.1 Purpose and scope The purpose of these guidelines is to provide dietitians in Australia and New Zealand with a summary of evidence based clinical questions related to the dietetic management of adult patients with cancer undergoing radiation therapy. For patients with cancer cachexia (clinical signs of anorexia, muscle wasting and weight loss of ≥5% over six months not attributable to inadequate intake alone) refer to the publication, Evidence based guidelines for the nutritional management of cancer cachexia.8 Weight loss due to mechanical obstruction or radiation therapy side-effects, which would be expected to resolve once the obstruction is bypassed/removed or treatment ceased, should not be classified as cachexia and is covered by these radiation therapy guidelines. The Evidence based practice guidelines for the nutritional management of patients receiving radiation therapy are focused on cancer types and patient populations at risk of unintentional weight loss. Radiation therapy is unique in that it takes a couple of weeks for side-effects to develop, they peak about two-thirds of the way through treatment and can continue for several weeks after the completion of radiation treatment. As outlined in these guidelines, all patients should be screened for nutritional risk to identify any individuals experiencing problems. Some patients may currently be well nourished but because they are undergoing treatment which is likely to result in nutritional problems it is recommended they receive an assessment by the dietitian. These guidelines therefore may not directly apply to patients who are generally not at nutritional risk, i.e. breast or prostate cancer. For these patients, nutritional goals during treatment should be firstly to maintain weight (prevent weight gain) and eat a healthy, well-balanced diet with additional strategies for managing symptoms of treatment as appropriate.9 After completing treatment, cancer survivors should aim to maintain a healthy weight and lifestyle.9 The World Cancer Research Fund (WCRF)10 report recommends that all cancer survivors receive nutritional care from an appropriately trained professional (physician and/or qualified nutrition professional) if able to do so, and unless otherwise advised, aim to follow the recommendations for diet, healthy weight and physical activity. The guidelines also state that the evidence does not support the use of high-dose supplements of micronutrients as a means of improving outcomes in people with a diagnosis of cancer.10 There is some evidence (NHMRC grade of recommendation: C) for the use of fish oil such as eicosopentaenoic acid (EPA) in patients experiencing cancer cachexia. For further details refer to the publication, Evidence based guidelines for the nutritional management of cancer cachexia.8 There is no evidence that patients receiving radiation therapy without any indication of cancer cachexia would benefit from EPA supplementation. Useful resources for people with cancer are included in Appendix I. The goal of the nutritional management of patients receiving radiation therapy is to improve dietary intake and maintain quality of life and physical function. It is not anticipated that nutrition therapy will impact on tumour response or survival (level I evidence;11 level IV evidence12) although the evidence is conflicting (level IV evidence13, 14). Future research in this area should measure loco-regional control and mortality as outcomes. The goals and outcomes of nutrition intervention will be dependent on the diagnosis and prognosis of the patient. For patients with end-stage disease the desired outcome is to maximise patient comfort and quality of life. The dietitian should liaise with patient/family/carers and the medical team to determine the level of intervention required. For comfort measures refer to the DAA paper: Nutrition priorities in palliative care of oncology patients.15 Dentition, symptom and pain management should be managed by the multidisciplinary team, e.g. dentists, nurses and speech pathologists. Patients experiencing dysphagia and/or salivary dysfunction need to receive review and follow up with the speech pathologist as required, which are not specifically detailed in these guidelines. The role of exercise and pharmacological agents on outcomes in patients receiving radiation therapy are also beyond the scope of these guidelines. Patients who cannot manage adequate dietary intake may require tube feeding depending on their prognosis and in consultation with the patient, their carers and medical team. It is important to consider any potential complications of tube feeding. Numerous level IV studies have reported success rates of ≥97% for percutaneous endoscopic gastrostomy (PEG) placement in head and neck cancer patients (level IV16-20). Minor complications from PEG placement range from 4% to 22% (level IV (n = 92),21 level IV (n = 79),22 respectively) with the minor complications being site infection, site bleeding, leaking, cellulitis, PEG obstruction and extrusion. Major complications range from 0 to 8% (level IV (n = 277),23 level IV (n = 79),22 respectively), where the complications were necrosis, abscess and PEG site metastasis. Procedure-related mortality was 0–1% (level IV (n = 277),23 level IV (n = 118),17 respectively). Literature searches for tube feeding in cancer primarily resulted in reports for head and neck cancer, with a small number for oesophageal cancer. Therefore, some of the recommendations are specific for head and neck cancer due to the lack of evidence for other patient groups. The enteral formulas used in the studies, when specified, were standard formulas (4.2 kJ/mL, 16–17% of energy from protein ± fibre). Patients with comorbidities must be managed in the context of their comorbidities, and nutritional management should be individualised and subject to the health professional's judgement in each individual case. In these guidelines, prophylactic gastrostomy/jejunostomy refers to using a gastrostomy/jejunostomy for patients who currently do not require tube feeding and are well nourished, but are anticipated to require it during treatment. Patients who present as malnourished should receive appropriate nutrition intervention, whether this is through counselling, supplements or tube feeding. 1.2 Consultation process A Steering Committee of dietitians with clinical and research expertise in the nutritional management of patients receiving radiation therapy and evidence based guideline development was convened in 2006. The committee produced the first draft of the clinical practice guidelines in March 2007. The draft was modelled on other guidelines developed for the nutritional management of disease. A statistician was consulted to clarify issues related to levels of evidence and incorporation of evidence from post-hoc analyses of randomised trials. In particular consultation was required on systematic reviews and guidelines which incorporated a range of studies with varying levels of evidence. For example, the systematic review by Trotti et al.24 included some RCTs investigating mucositis treatment (level II studies) but most of the studies reported weight loss as a ‘by-product’ of the main investigation and therefore are observational studies (level IV) which has implications depending on the clinical question to be answered. A workshop of dietitians was convened at the Queensland Professional Development Day (23 March 2007) to consider the draft guidelines and provide peer review. The 15 participants evaluated the guidelines and provided feedback using the evaluation form provided. Participant feedback from the workshop and consumer feedback, which was arranged through the Queensland Cancer Council, were incorporated into a second draft. These draft guidelines were then distributed to all previous workshop participants, DAA oncology experts, the DAA oncology interest group, international dietitians who had expressed an interest in participation, oncologists, nurses, speech pathologists and other professionals working in the area of cancer for targeted peer and expert evaluation and feedback. This draft was also presented and evaluated at a workshop for oncology dietitians in Auckland, New Zealand in June 2007. These guidelines have been presented to a multidisciplinary audience including oncologists, surgeons, nurses, pharmacists, radiation therapists and speech pathologists attending the Australia and New Zealand Head and Neck Society and Clinical Oncological Society of Australia conferences in 2007. Participant feedback from the workshop and peer and expert review (40 evaluations) were incorporated into a third draft. Participant feedback was incorporated into the final document, which was submitted to the DAA Practice Advisory Committee and the DAA Board for endorsement. 1.3 Methods 1.3.1 Framework In the development of these guidelines for dietitians, the approach taken has combined the requirement for evidence in answering clinical questions but integrating the evidence into a recognised nutrition model of care (Figure 1). Lacey and Pritchett1 refer to the Nutrition Care Model; a trigger event which identifies where and how the patient/client is identified for nutrition care; the nutrition care process which specifies the cycle of essential components of effective care; and the nutrition-related outcomes, which lists the most likely areas to observe results produced by or influenced by nutrition care: Figure 1Open in figure viewerPowerPoint Framework for the development of Evidence based practice guidelines for the nutritional management of patients receiving radiation therapy (adapted from Lacey and Prichett2 and Hakel-Smith and Lewis4). • Appropriate access to nutrition care (nutrition screening; nutrition assessment; collection of evidence) • Quality nutrition care—nutrition diagnosis, nutrition intervention (establishing goals; prescription and implementation) • Nutrition monitoring and evaluation—outcomes (measuring and evaluating outcomes). Although the nutrition care process is common to the nutritional management of many clinical conditions, in these guidelines the questions developed and the outcomes measured are specific to the nutritional management of patients receiving radiation therapy. In areas where radiation therapy-specific data are lacking, results from studies of other groups of patients with cancer have been included, and identified as such. 1.3.2 Literature search The Cochrane Database of Systematic Reviews, CENTRAL, MEDLINE (via Ovid), EMBASE, CINAHL (Ebscohost) and PubMed databases were searched in March 2006 and repeated in March 2007. Approximately 50 suitable articles relating to nutrition intervention in radiation therapy were identified. Search terms included radiotherapy, radiation therapy, nutrition support, dietary interventions, enteral nutrition, gastrostomy/jejunostomy, clinical and randomised controlled trials. There was no restriction on dates of publication. Non-English, paediatric and case report papers were excluded. Relevant recent articles and articles from other reference lists (n = 11) were also added to the list. The search terms and the respective results for each of the databases are available for review. Each article was appraised independently by at least two members of the Steering Committee. Please refer to the web-based version of these guidelines for a more detailed methodology. 1.3.3 Literature critique This best available evidence is presented and used as a basis for providing recommendations about clinical practice. The strength of the evidence was assessed using the level of evidence rating system recommended by the NHMRC publication, A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines.3 A table was developed to collate the evidence for screening, assessment, intervention, monitoring and evaluation against key outcome indicators. Levels of evidence, quality of study design, the strength of the effect and relevance to practice were considered in ranking the evidence. The evidence rating classifications used in the guidelines are as follows: Level I Evidence obtained from a systematic review of all relevant randomised controlled trials Level II Evidence obtained from at least one properly designed randomised controlled trial Level III-1 Evidence obtained from well-designed pseudo-randomised controlled trials (alternate allocation or some other method) Level III-2 Evidence obtained from comparative studies with concurrent control and allocation not randomised (cohort studies), case–control studies, or interrupted time series with a control group Level III-3 Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel group Level IV Evidence obtained from case studies, either post-test or pre- and post-test. For intervention studies, level I is recommended as the gold standard. Clinical nutrition studies are difficult to complete in a blinded fashion and often the group most likely to benefit from the intervention is excluded for ethical reasons. For these reasons, recommendations based on lower levels of evidence but with strong design quality, strength of effect and relevance are included. NHMRC Additional Levels of Evidence and Grades of Recommendations for Developers of Guidelines—Pilot Program 2005 were used to assess the body of evidence and provide an indication to the strength of each guideline recommendation.25 The grades of recommendation are: Level A Body of evidence can be trusted to guide practice Level B Body of evidence can be trusted to guide practice in most situations Level C Body of evidence provides some support for recommendation(s) but care should be taken in its application Level D Body of evidence is weak and recommendation(s) must be applied with caution. The five components that are considered in judging the body of evidence are the volume of evidence, consistency of the results, potential clinical impact of the proposed recommendation, the generalisability and applicability of the body of evidence to the Australian health-care context. A recommendation cannot be graded as A or B unless the volume and consistency of the evidence components are both graded A or B. 1.4 Addressing potential barriers and evaluation of guidelines The guidelines recommend intensive dietary counselling which may include the use of supplements. Patients at high nutritional risk may require tube feeding. These recommendations have potential resource implications that may include change to staff roles, extra staff and increased use of supplements or tube feeding. Therefore, when using these guidelines the potential organisational and cost barriers need to be considered. A series of workshops will be conducted around Australia by members of the Steering Committee on how to implement the guidelines using worked examples on addressing potential organisational and cost barriers. Prior to the 2010 guideline review, an evaluation of the guidelines and rates of implementation will be conducted among DAA Oncology Interest Group members using a structured questionnaire. 1.5 Review process The guidelines are intended to be reviewed every 3 years to ensure they remain current and that the evidence is considered in the context of the evolving nature of radiation therapy techniques. Nutrition RCTs conducted in patients receiving chemotherapy published after the original development of these guidelines will be included in the review process and hence it is anticipated that these guidelines will eventually relate to the nutritional management of patients with cancer (therefore combining cachexia and radiation therapy guidelines and possibly including chemotherapy if more papers are published in this area). Responsibility for the review lies with the guideline Steering Committee. Next review date: 2010. The guidelines, including full methodology, are included on the DAA website (http://www.daa.asn.au) under the Guidelines section. 1.6 Editorial independence The guidelines were developed without the assistance of external funding. Where guideline development team members were authors of a published article, other team members of the guideline Steering Committee evaluated the article for levels of evidence. Guideline development team potential conflict of interest declarations for conference attendance includes: J Bauer (Abbott, 2006; Nutricia, 2007; Novartis, 2007) and E Isenring (Nutricia, 2007). S Ash, T Brown, J Hill, K Kaegi, M Reeves and S Thomas did not declare any potential conflict of interest. 2: CLINICAL QUESTIONS AND EVIDENCE BASED STATEMENTS Appropriate access to care Nutrition screening and referral Clinical question 1. How should patients be identified for referral to the dietitian (and/or nutrition support) in order to maximise nutrition intervention strategies? Recommendation All patients receiving radiation therapy to the GIT or head and neck area should be referred to the dietitian (and/or nutrition support). NHMRC grade of recommendation: B Patients receiving radiation therapy to the oesophageal or head and neck area should be referred prior to commencement of radiation therapy for consideration of a prophylactic gastrostomy/jejunostomy. Other patients at nutritional risk can be identified using a nutrition screening tool which has been validated in patients" @default.
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