Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia
- 1 February 2010
- journal article
- research article
- Published by Oxford University Press (OUP) in The Oncologist
- Vol. 15 (2), 200-211
- https://doi.org/10.1634/theoncologist.2009-0153
Abstract
Purpose. A phase III, randomized study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia—lean body mass (LBM), resting energy expenditure (REE), and fatigue—and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines. Patients and Methods. Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were randomly assigned to one of five treatment arms: arm 1, medroxyprogesterone (500 mg/day) or megestrol acetate (320 mg/day); arm 2, oral supplementation with eicosapentaenoic acid; arm 3, L-carnitine (4 g/day); arm 4, thalidomide (200 mg/day); and arm 5, a combination of the above. Treatment duration was 4 months. Results. Analysis of variance showed a significant difference between treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms. Conclusion. The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite, IL-6, GPS, and ECOG PS score was the combination regimen that included all selected agents.Keywords
This publication has 62 references indexed in Scilit:
- An inflammation-based prognostic score and its role in the nutrition-based management of patients with cancerProceedings of the Nutrition Society, 2008
- Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover studyBritish Journal of Cancer, 2008
- Results of a pilot study of the effects of celecoxib on cancer cachexia in patients with cancer of the head, neck, and gastrointestinal tractHead & Neck, 2007
- Evaluation of an inflammation‐based prognostic score in patients with metastatic renal cancerCancer, 2007
- Anorexia in cancer: role of feeding-regulatory peptidesPhilosophical Transactions B, 2006
- Fatigue in gynaecological cancer patients: a pilot studySupportive Care in Cancer, 2005
- Managing Cancer-Related Anorexia/CachexiaDrugs, 2001
- Effects of medroxyprogesterone acetate on food intake, body composition, and resting energy expenditure in patients with advanced, nonhormone-sensitive cancerCancer, 1998
- Food intake and body temperature responses of rats to recombinant human interleukin-1β and a tripeptide interleukin-1β antagonistPhysiology & Behavior, 1992
- A controlled trial of megestrol acetate on appetite, caloric intake, nutritional status, and other symptoms in patients with advanced cancerCancer, 1990