Q19. What are the effective methods of implementation to ensure positive outcomes?

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Q19. What are the effective methods of implementation to ensure positive outcomes?

Summary

The Evidence Based Practice Guidelines for Nutritional Management of Patients Receiving Radiation Therapy[1], which have been updated to also include management of patients receiving chemotherapy are available to guide practice for all types of cancer. There are four systematic reviews (three level I, one level III), examining nutrition interventions in patients receiving radiotherapy or chemoradiotherapy for head and neck cancer. Two positive quality reviews[2][3] summarise all types of nutrition interventions (10 studies) and one neutral quality review[4] focuses on tube feeding studies (1 study). The fourth systematic review on tube feeding by Wang et al.[5] is level III evidence (a review of level III-IV studies) and of neutral quality. There are many lower level evidence studies (one level III-1 neutral quality[6], one level III-1 negative quality[7], eleven level III-2 neutral quality[8][9][10][11][12][13][14][15][16][17][18] and three III-2 negative quality [19][20][21], two level III-3 positive quality[22][23], three level III-3 neutral quality [24][25][26], and thirteen level IV neutral quality studies [27][28][29][30][31][32][33][34][35][36][37][38][39].

It is important to distinguish between the different types of tube feeding, approaches (proactive versus reactive) and timing. Tube feeding can be provided via a nasogastric tube or a gastrostomy tube (which may be placed endoscopically, radiologically or surgically). A proactive approach to nutritional management is a feeding tube placed prior to treatment either in anticipation of its need (prophylactic gastrostomy) or due to significant nutritional compromise or dysphagia (therapeutic gastrostomy). A reactive approach to nutritional management is a feeding tube placed during treatment only when it becomes clinically indicated due to significant nutritional compromise or dysphagia, is a reactive feeding tube, and may be either a nasogastric tube or gastrostomy.

Dietary counselling and/or Nutritional supplements

There are two level I positive quality studies that report on outcomes with dietary counselling and/or oral supplements[2][3]. The review by Garg et al consisted of five RCT’s (Arnold et al 1989, Nayel et al 1992, Lovik et al 1996, Isenring et al 2004, Ravsco et al 2005). The review by Languis et al consisted of three additional RCT’s or papers from previously reported RCT’s (Macia et al 1991, Isenring et al 2007, Van den Berg et al 2010). Overall they both conclude that dietary counselling and/or nutritional supplements have beneficial effects on nutritional intake, nutritional status and quality of life.

Prophylactic tube feeding (Nasogastric and Gastrostomy) versus Oral intake alone

Tube feeding is specifically recommended for patients with head and neck cancer if the tumour is obstructive, thereby impacting on swallow function or if severe mucositis is expected[40]. The first RCT to place tubes prophylactically using nasogastric tubes (two reports of same trial[41][42]) established that nasogastric tube feeding versus oral intake alone is effective to increase energy and protein intakes and achieve less weight loss. This RCT was included in two recent systematic reviews, which concluded that tube feeding improves nutritional intake and nutritional status compared to oral intake alone[3] and that nutritional status appeared to be maintained or improved with prophylactic tube placement[2]. There have been four additional lower level studies in five reports (one level III-2 neutral quality, three level III-2 negative quality, one level IV positive quality) which have compared prophylactic tube feeding, generally with a gastrostomy, to oral intake alone with consistent beneficial findings[21][20][43][44][45]. With the clear benefits of tube feeding over oral intake alone, the question then arises as to which type of tube is preferred.

Reactive tube feeding: Nasogastric versus Gastrostomy

There have been two systematic reviews (one level I neutral quality, one level I positive quality) which compared methods of tube feeding[4][3], however each review only could include one RCT[46] which was deemed to have a high degree of bias. Corry et al. (2008), and therefore the optimal type of tube could not be concluded within the context of a high level study. This study (level II neutral quality) compared a reactive approach to tube feeding between a gastrostomy and nasogastric tube and found that, although the gastrostomy group used the tube for significantly longer, there were significant benefits with weight outcomes at six weeks post treatment (but no difference at six months), more tube dislodgements in the nasogastric group and no impact on overall quality of life. However, there were differences for specific aspects of quality of life. During the first week of tube placement, patients with a gastrostomy reported more pain, while patients with a nasogastric tube reported more body image concerns. At six weeks post treatment, patients with a nasogastric tube reported significantly more body image issues, inconvenience, discomfort associated with feeding, and greater impact on family life and interference with social activities than patients with a gastrostomy. There have been four other lower level studies (one level III-1 negative quality, one level III-2 neutral quality, one level III-2 negative quality, one level IV neutral quality) also comparing outcomes with the two types of tubes[7][47][19][33] which have been summarised in the systematic review by Wang et al (level III). However, the conclusion of this systematic review becomes further confused by the inclusion of three additional studies comparing prophylactic tube placement to reactive tube feeding. As the studies within the review by Wang et al are not comparable in terms of timing of tube feeding or placement method which will obviously impact on outcomes, this makes drawing valid conclusions challenging. Both earlier systematic reviews[48][3] report there is no conclusive evidence to support best method of tube feeding and that the decision regarding tube feeding should be individualised to suit the anticipated duration of enteral tube feeding, the patient’s psychological characteristics and personal preference, as well as their medical condition for undergoing any required procedures for tube placement.

Prophylactic gastrostomy feeding versus Reactive tube feeding (either Nasogastric or Gastrostomy)

The first systematic review[2] only included one RCT (2 reports – Daly et al 1984, Hearne et al 1985) and concluded that prophylactic tube placement achieved superior nutrition outcomes compared to oral intake alone. Although not clearly stated, this study was likely to be more of a therapeutic approach rather than true prophylactic placement as all patients were commenced on tube feeding to some degree in week 1-2 of treatment. In addition, one of the limitations is the study was undertaken in patients receiving radiotherapy alone whereas patients typically now receive concurrent chemoradiotherapy. Finally, as tube feeding has been shown to be superior to oral intake alone, it has become more common practice to compare the timing of tube feeding approaches rather than to oral intake alone. Therefore, the second systematic review[3] now includes two new RCT’s (two level II positive quality) comparing prophylactic gastrostomy placement with reactive tube feeding if required (Salas et al 2009 – reactive gatrostomy, Silander et al 2012 – reactive tube feeding). In this review, it was suggested that prophylactic gastrostomy was not superior to reactive tube feeding when longer term outcomes were assessed, but may provide some short term benefit.

One RCT compared prophylactic gastrostomy with reactive gastrostomy (when required due to dysphagia or weight loss) and found no effect on body mass index (BMI) at the end of treatment or at 6 months but a positive effect on quality of life both at the end of treatment (for mental scores) and at six months post treatment (for mental scores, physical scores and global health status)[49]. The second RCT compared prophylactic gastrostomy with reactive tube feeding (when deemed necessary) and found no significant difference in length of hospital stay and no difference in weight loss/malnutrition at 3 months, 6 months, 1 year and 2 years. However, in the prophylactic gastrostomy group there was a trend to less malnourished patients 2 months after the commencement of treatment and improved quality of life at all time points (2 months, 3 months, six months, 1 year and 2 years post treatment) with the most prominent differences at 6 months including the global quality of life[50]. An additional study on the same cohort (level II neutral quality), found no significant difference in energy and protein intakes between groups, although the prophylactic gastrostomy group tended to be higher[51].

There have been 16 lower level evidence studies (seven level III-2 neutral quality, two level III-3 positive quality, one level III-3 neutral, one level IV positive quality, five level IV neutral quality) which have compared various nutritional, clinical and survival outcomes in patients with a prophylactic gastrostomy[17][11][9][52][36][16][14][22][23][53][27][54][31][32][26][18]. These lower level studies have all shown positive nutritional benefits with less weight loss. Three of these studies were summarised in the systematic review by Wang et al[5], but again, conclusions from this review are limited as the studies are mixed with reactive tube feeding studies and do not comprehensively include all the relevant literature. These contradictory differences can be largely explained by differences in timeframe. The majority of these studies have looked at short term nutritional outcomes during treatment, whereas the RCT’s have looked at longer term nutritional outcomes (>6 months). It should be noted that it is unreasonable to expect to see long term differences in weight attributable to nutrition intervention during treatment as other variables may significantly impact on diet and healthy lifestyle, and nutrition outcome measures such as weight, following a cancer diagnosis and subsequent treatment. Finally, a number of these lower level studies have also demonstrated positive clinical outcomes such as reduced admissions, LOS, and treatment interruptions, with no impact on survival outcomes.

Psychosocial considerations with tube feeding

One study[34] assessed the quality of life of patients on home enteral nutrition (HEN) either using a nasogastric or gastrostomy tube. Tube feeding was determined to be well tolerated physically but it did, however, cause psychosocial distress. There did appear to be a degree of adaptation to HEN with significant improvements in quality of life from day 7 to day 28 post tube placement. In a study comparing patients with a gastrostomy in-situ to those that either had one removed or did not have one at all, overall quality of life appeared reduced in the gastrostomy group with particular effects on relationships, family life, clothing and interference with hobbies, leisure and social activities[10]. However, it is also important to remember that quality of life may also be affected by malnutrition. A level IV neutral quality qualitative study[37] examining patient and caregivers’ views on gastrostomy placement found that, although the tube was viewed positively in providing nutrition support and preventing weight loss, it raised issues of the impact of the tube on social and daily activities and intimacy. Another qualitative study[39] investigating patient experiences of gastrostomy tube feeding identified three perspectives: positive adaptation to and acceptance of tube feeding; ambivalence between cognitive acceptance and affective rejection of the gastrostomy tube; and tube-focused anxiety and fear, highlighting the need for an individualised approach to nutritional care. With the patient / carers experience the studies also reflected the side effects of treatment and how patients use their tube for coping with the treatment they have had and how it was their lifeline to living.

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Recommendation Grade
Dietary counselling and/or Nutritional supplements

Dietary counselling and/or supplements are effective methods of nutrition intervention, and weekly dietitian contact improves outcomes in patients receiving radiotherapy.

A
Prophylactic gastrostomy feeding versus Reactive tube feeding (either Nasogastric or Gastrostomy)

Prophylactic tube feeding compared to reactive tube feeding does not improve nutrition outcomes (weight loss/BMI) in long-term post-treatment phase (6 months post treatment and beyond).

B
Prophylactic tube feeding (Nasogastric and Gastrostomy) versus Oral intake alone

For patients not tolerating adequate intake orally, tube feeding should be used to improve nutritional intake and minimise weight loss.

B
Prophylactic gastrostomy feeding versus Reactive tube feeding (either Nasogastric or Gastrostomy)

Prophylactic tube feeding compared to a reactive tube feeding approach may improve quality of life in long-term post-treatment phase (>6 months post treatment).

B
Prophylactic tube feeding (Nasogastric and Gastrostomy) versus Oral intake alone

Prophylactic tube feeding compared to oral intake alone demonstrates improved nutrition outcomes with less weight loss.

B
Psychosocial considerations with tube feeding

Patients who are unable to eat and are reliant on tube feeding should be screened for distress and provided with psychosocial supports to assist with quality of life.

C
Prophylactic tube feeding (Nasogastric and Gastrostomy) versus Oral intake alone

Practice Point The optimal method of tube feeding (nasogastric vs gastrostomy) remains unclear due to a lack of comparative studies therefore, the risks and benefits of both proactive and reactive approaches should be discussed with the patient to ensure individualised nutritional care at the point of diagnosis .

B
Reactive tube feeding: Nasogastric versus Gastrostomy

Reactive tube feeding (nasogastric or gastrostomy) results in similar nutritional and clinical outcomes and although no difference in global quality of life, there are differences in domains of quality of life and tube complications which should be discussed with the patient.

B
Prophylactic gastrostomy feeding versus Reactive tube feeding (either Nasogastric or Gastrostomy)

Prophylactic tube feeding compared to reactive tube feeding demonstrates improves nutrition outcomes (weight loss), quality of life and clinical outcomes (reduced hospital admissions, LOS and treatment interruptions) during the treatment phase.

B

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References

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