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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Oesophageal cancer and cachexia: the effect of short-term treatment with thalidomide on weight loss and lean body mass.
Alimentary Pharmacology & Therapeutics 2003 March 2
BACKGROUND: Cachexia is common in patients with advanced cancer and has a direct impact on well-being and mortality.
AIM: To test the hypothesis that thalidomide can promote weight gain and lean body mass in patients with advanced oesophageal cancer.
METHODS: In an open-label study, 11 patients with non-obstructing and inoperable oesophageal cancer were established on an isocaloric diet for 2 weeks, followed by 2 weeks on thalidomide, 200 mg daily. The primary end-points were weight change and lean body mass. Secondary end-points were quality of life and changes in resting energy expenditure.
RESULTS: Ten patients completed the study protocol. The average caloric intake remained the same throughout the study period in all patients. Nine of 10 patients (95% confidence interval, 0.60, 0.98) lost weight on diet alone. The mean weight gain on thalidomide in the following 2 weeks was 1.29 kg (median, 1.25 kg). A similar trend was shown in the lean body mass. Eight of nine patients (95% confidence interval, 0.57, 0.98) initially lost lean body mass on diet alone (missing data in one patient). The mean gain in lean body mass on thalidomide in the following 2 weeks was 1.75 kg (median, 1.33 kg).
CONCLUSIONS: Thalidomide treatment appeared to reverse the loss of weight and lean body mass over the 2-week trial period.
AIM: To test the hypothesis that thalidomide can promote weight gain and lean body mass in patients with advanced oesophageal cancer.
METHODS: In an open-label study, 11 patients with non-obstructing and inoperable oesophageal cancer were established on an isocaloric diet for 2 weeks, followed by 2 weeks on thalidomide, 200 mg daily. The primary end-points were weight change and lean body mass. Secondary end-points were quality of life and changes in resting energy expenditure.
RESULTS: Ten patients completed the study protocol. The average caloric intake remained the same throughout the study period in all patients. Nine of 10 patients (95% confidence interval, 0.60, 0.98) lost weight on diet alone. The mean weight gain on thalidomide in the following 2 weeks was 1.29 kg (median, 1.25 kg). A similar trend was shown in the lean body mass. Eight of nine patients (95% confidence interval, 0.57, 0.98) initially lost lean body mass on diet alone (missing data in one patient). The mean gain in lean body mass on thalidomide in the following 2 weeks was 1.75 kg (median, 1.33 kg).
CONCLUSIONS: Thalidomide treatment appeared to reverse the loss of weight and lean body mass over the 2-week trial period.
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