Simple nutritional intervention in patients with advanced cancers of the gastrointestinal tract, non-small cell lung cancers or mesothelioma and weight loss receiving chemotherapy: a randomised controlled trial

Our plain-English summary of Simple nutritional intervention in patients with advanced cancers of the gastrointestinal tract, non-small cell lung cancers or mesothelioma and weight loss receiving chemotherapy: a randomised controlled trial, by C. Baldwin, A. Spiro, C. McGough, et al (Journal of Human Nutrition and Dietetics, 2011).

The study

• Authors: C. Baldwin, A. Spiro, C. McGough, A.R. Norman, A. Gillbanks, K. Thomas, D. Cunningham, M. O'Brien, H.J. Andreyev
• Journal: Journal of Human Nutrition and Dietetics
• Published: 2011;24(5):431-40
• Type of article: Randomized trial
• Cited by: 115 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Background: Weight loss in patients with cancer is common and associated with a poorer survival and quality of life. Benefits from nutritional interventions are unclear. The present study assessed the effect of dietary advice and/or oral nutritional supplements on survival, nutritional endpoints and quality of life in patients with weight loss receiving palliative chemotherapy for gastrointestinal and non-small cell lung cancers or mesothelioma.

Methods: Participants were randomly assigned to receive no intervention, dietary advice, a nutritional supplement or dietary advice plus supplement before the start of chemotherapy. Patients were followed for 1 year. Survival, nutritional status and quality of life were assessed.

Results: In total, 256 men and 102 women (median age, 66 years; range 24-88 years) with gastrointestinal (n = 277) and lung (n = 81) cancers were recruited. Median (range) follow-up was 6 (0-49) months. One-year survival was 38.6% (95% confidence interval 33.3-43.9). No differences in survival, weight or quality of life between groups were seen. Patients surviving beyond 26 weeks experienced significant weight gain from baseline to 12 weeks, although this was independent of nutritional intervention.

Conclusions: Simple nutritional interventions did not improve clinical or nutritional outcomes or quality of life. Weight gain predicted a longer survival but occurred independently of nutritional intervention.

© 2011 The Authors. Journal of Human Nutrition and Dietetics © 2011 The British Dietetic Association Ltd.

In plain English

This randomised trial tested simple nutrition support in patients with weight loss starting palliative chemotherapy for advanced gastrointestinal cancer, non-small cell lung cancer or mesothelioma. It did not study asbestos. The 358 patients were randomly assigned to no dietary intervention, dietary advice, a daily supplement, or both, for 6 weeks. 81 were listed as lung cancer; mesothelioma was not counted separately. One-year survival was 38.6% (95% confidence interval 33.3 to 43.9) overall, with no significant differences between groups. Quality of life did not differ significantly either. Among 68 patients weighed at one year, those given dietary advice were heavier (P = 0.04). The authors urged caution, and it was not significant once patients missing at one year were included. Patients surviving beyond 26 weeks gained more weight by 12 weeks than non-survivors, regardless of group. Supplement diaries were returned by 62 of 150 patients; recorded diaries showed 19% taking the full supplement by week 6 and 48% taking none. The authors concluded that simple nutritional interventions did not improve outcomes, noting the trial was stopped early and poor compliance made firm conclusions difficult.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Randomised controlled trial with four groups (two-by-two factorial analysis), stopped early on the advice of an independent data monitoring committee
• Who was studied: 358 adults (256 men, 102 women) with weight loss and metastatic or locally advanced cancers, about to receive palliative chemotherapy. 277 had gastrointestinal cancers and 81 were listed under lung cancer. Eligibility included non-small cell lung cancer and mesothelioma, but the article gives no separate count of mesothelioma patients. Patients were recruited from 2002 until the trial stopped in 2006, mainly at the Royal Marsden Hospital, UK, plus other UK centres and one in Melbourne, Australia.
• Exposure: No asbestos exposure was studied. Patients were randomly assigned to a 6-week nutritional intervention in one of four arms: no dietary intervention; advice to eat an extra 600 kcal per day; one daily milk-based nutritional supplement sachet (588 kcal) plus a multivitamin; or advice plus supplement.
• Main results:
  • Overall 1-year survival for all patients was 38.6% (95% CI 33.3 to 43.9), with no significant differences in overall survival between any of the groups
  • Adjusted hazard ratios were: dietary advice versus no advice 0.840 (95% CI 0.653 to 1.08); supplement versus no supplement 1.016 (0.791 to 1.306); any intervention versus none 0.977 (0.733 to 1.302)
  • Changes in quality of life from baseline to 6 and 26 weeks did not differ significantly between groups receiving dietary advice versus none, or supplements versus none
  • Among patients measured at 52 weeks, mean weight change was 4.78 kg in the dietary advice group (n = 31) and 1.36 kg in the no-advice group (n = 37). This difference was significant (P = 0.04), but the authors cautioned that the numbers (68) were small. The difference was not significant in the intention-to-treat analysis including patients missing at 1 year.
  • Mean weight change from baseline to 12 weeks was 0.58 kg (SD 2.47) in patients surviving beyond 26 weeks and minus 0.66 kg (SD 3.76) in those who did not (P = 0.002). This was independent of group allocation.
  • Supplement diaries were returned by 62 (41%) of 150 patients. In recorded compliance, the share taking the full prescribed supplement fell from 31% in week 1 to 19% by week 6. The share unable to take any supplement rose to 48% by week 6.
• The authors' conclusion: The authors concluded that simple nutritional interventions did not improve clinical or nutritional outcomes or quality of life. They found that weight gain predicted longer survival but occurred independently of the nutritional intervention.
• Limitations the authors state:
  • The trial was stopped prematurely on the advice of the independent data monitoring committee, with 358 of a planned 660 patients randomised
  • When the trial was stopped, only half the predicted number of deaths had occurred
  • Patients did not take the intervention as prescribed, making it difficult to draw conclusions about whether nutritional interventions work in this population
  • Few patients completed food diaries (60 of 236 at baseline), so energy intake and food-based compliance could not be analysed
  • Adding patients with lung cancer (which is a different disease from gastrointestinal cancer) may have influenced the findings
  • Trial dietitians were not blinded to treatment group, which may have influenced assessment of subjective outcomes. Patients may also have obtained nutritional information from other sources.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Mesothelioma.

Medical terms in this study, explained in our Lexicon: Non-Small Cell Lung Cancer, Mesothelioma, Chemotherapy, Quality of Life, Palliative Care, confidence interval.

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