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Clinical Trial
. 2003 Oct;52(10):1479-86.
doi: 10.1136/gut.52.10.1479.

Effect of a Protein and Energy Dense N-3 Fatty Acid Enriched Oral Supplement on Loss of Weight and Lean Tissue in Cancer Cachexia: A Randomised Double Blind Trial

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Free PMC article
Clinical Trial

Effect of a Protein and Energy Dense N-3 Fatty Acid Enriched Oral Supplement on Loss of Weight and Lean Tissue in Cancer Cachexia: A Randomised Double Blind Trial

K C H Fearon et al. Gut. .
Free PMC article

Abstract

Aim: N-3 fatty acids, especially eicosapentaenoic acid (EPA), may possess anticachectic properties. This trial compared a protein and energy dense supplement enriched with n-3 fatty acids and antioxidants (experimental: E) with an isocaloric isonitrogenous control supplement (C) for their effects on weight, lean body mass (LBM), dietary intake, and quality of life in cachectic patients with advanced pancreatic cancer.

Methods: A total of 200 patients (95 E; 105 C) were randomised to consume two cans/day of the E or C supplement (480 ml, 620 kcal, 32 g protein +/- 2.2 g EPA) for eight weeks in a multicentre, randomised, double blind trial.

Results: At enrolment, patients' mean rate of weight loss was 3.3 kg/month. Intake of the supplements (E or C) was below the recommended dose (2 cans/day) and averaged 1.4 cans/day. Over eight weeks, patients in both groups stopped losing weight (delta weight E: -0.25 kg/month versus C: -0.37 kg/month; p = 0.74) and LBM (Delta LBM E: +0.27 kg/month versus C: +0.12 kg/month; p = 0.88) to an equal degree (change from baseline E and C, p<0.001). In view of evident non-compliance in both E and C groups, correlation analyses were undertaken to examine for potential dose-response relationships. E patients demonstrated significant correlations between their supplement intake and weight gain (r = 0.50, p<0.001) and increase in LBM (r = 0.33, p = 0.036). Such correlations were not statistically significant in C patients. The relationship of supplement intake with change in LBM was significantly different between E and C patients (p = 0.043). Increased plasma EPA levels in the E group were associated with weight and LBM gain (r = 0.50, p<0.001; r = 0.51, p = 0.001). Weight gain was associated with improved quality of life (p<0.01) only in the E group.

Conclusion: Intention to treat group comparisons indicated that at the mean dose taken, enrichment with n-3 fatty acids did not provide a therapeutic advantage and that both supplements were equally effective in arresting weight loss. Post hoc dose-response analysis suggests that if taken in sufficient quantity, only the n-3 fatty acid enriched energy and protein dense supplement results in net gain of weight, lean tissue, and improved quality of life. Further trials are required to examine the potential role of n-3 enriched supplements in the treatment of cancer cachexia.

Figures

Figure 1
Figure 1
Patient disposition. Number of patients lost to follow up (enrolment to baseline+baseline to week 4+week 4 to week 8).
Figure 2
Figure 2
Effect of protein and calorie dense oral supplements, with or without n-3 fatty acids, on weight change in patients with pancreatic cancer cachexia. *NS (p = 0.49) at baseline, 0.95 at four weeks, and 0.74 at eight weeks between groups; **p<0.001 within group comparisons to baseline.
Figure 3
Figure 3
Effect of protein and calorie dense oral supplements, with or without n-3 fatty acids, on change in lean body mass in patients with pancreatic cancer cachexia. *NS (p = 0.85) at baseline, 0.95 at four weeks, and 0.88 at eight weeks between groups; **p<0.001 within group comparisons to baseline.
Figure 4
Figure 4
Relationship between oral supplement intake, with or without n-3 fatty acids, and weight (A, B) or lean body mass (C, D) of patients with pancreatic cancer cachexia after eight weeks of supplementation.
Figure 5
Figure 5
Effect of intake of protein and calorie dense oral supplement with n-3 fatty acids on change in weight and lean body mass at eight weeks in patients with pancreatic cancer cachexia.
Figure 6
Figure 6
Relationship between plasma phospholipid eicosapentaenoic acid (EPA) levels and change in lean body mass at eight weeks in patients consuming the protein and calorie dense oral supplement with n-3 fatty acids.

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