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my personal edition > oncology other > news
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DGDispatch
Cocktail of Antioxidants, Progestagen, and Celecoxib (Celebrex) Effective in Cancer-Related Anorexia, Cachexia: Presented at MASCC-ISOO
By Paula Moyer
GENEVA, SWITZERLAND -- July 15, 2005 -- A combination of antioxidant supplements, nutritional supplements, and cyclo-oxygenase 2 (COX-2) inhibitors is effective in treating cancer-related anorexia and cachexia, according to findings presented here.
Results of an interim analysis of this phase 2 study July 2nd at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society for Oral Oncology (ISOO) 17th International Symposium.
The interim analysis showed that most of the 31 patients for whom data were evaluable were either responders or high responders, according to principal investigator Giovanni Mantovani, MD, head of medical oncology, University of Cagliari, Cagliari, Italy.
The study regimen consisted of the following components: a diet with at least 400 mg daily of polyphenols; 2 cans/day of oral pharmaco-nutritional support enriched with n- 3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA); 500 mg daily of medroxyprogesterone acetate; antioxidant treatment consisting of daily treatment with 300 mg of alpha lipoic acid, 2.7 g of carbocysteine lysine salt, 400 mg of vitamin E, 30,000 international unites of vitamin A, and 500 mg of vitamin C; and 200 mg daily of celecoxib (Celebrex).
The investigators recruited 39 patients with advanced tumors at different anatomical sites to undergo the treatment, which was 16 weeks in duration.
The investigators evaluated the response in the following domains: 1) clinical, using both objective clinical response and Eastern Cooperative Oncology Group Performance Status; 2) nutritional, by assessing lean body mass, appetite, and resting energy expenditure (REE); 3) laboratory measures, by assessing proinflammatory cytokines, leptin, reactive oxygen species and antioxidant enzymes; 4) quality of life, with the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire subscales.
Among evaluable patients, the lean body mass increased an average of 1.0 kg after 1 month, which was not significant; 1.9 kg after 2 months (P =.032), and 1.9 kg after 4 months (P =.038).
Weight gain was related to patients' self-reports of increased appetite during treatment. Serum levels of proinflammatory cytokines significantly decreased during treatment, while serum leptin levels increased significantly during the study period.
Reactive oxygen species levels, which measure oxidative stress, decreased during the same period. Scores on all EORTC quality-of-life subscales significantly improved after 1, 2, and 4 months of treatment.
In the 31 patients for whom data are available, 17 responded to treatment and 13 categorized as responders and 4 as high responders.
Therefore, the investigators concluded that this combination treatment is effective, reported Dr. Mantovani. Analyses are underway to further assess the findings.
[Presentation title: Phase II Study with Antioxidants, Pharmaco-Nutritional Support, Progestagen, Anti-COX-2 Showing Efficacy and Safety in Patients With Cancer-Related Anorexia/Cachexia (CACS) and Oxidative Stress (OS). Abstract 03-012]
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