Cachexia, Oxidative Stress, Antioxidants, Pharmaco-nutrition Ova

Cancer-related anorexia/cachexia (CACS) and oxidative stress (OS): A phase II study with antioxidants, pharmaco-nutritional support, progestagen and anti-COX-2.

Giovanni Mantovani, Clelia Madeddu, Maria Rita Lusso, Giulia Gramignano, Elena Massa, Giorgio Astara, Mariele Dessì, Alberta Stara, Antonio Macciò, Roberto Serpe. Department of Medical Oncology, University of Cagliari, Cagliari, Italy.

Objective.A phase II non randomized study has been designed to enroll 39 advanced cancer patients with symptoms of CACS/OS, with the aim to evaluate the efficacy and tolerability of an innovative approach consisting of: diet with high polyphenols content (400 mg), oral pharmaco-nutritional support enriched with n-3 PUFA (EPA, DHA) 2 cans (237 ml each)/day, medroxyprogesterone acetate 500 mg/day, antioxidant treatment (alpha lipoic acid 300 mg/day + carbocysteine lysine salt 2.7 g/day + vitamin E 400 mg/day + vitamin A 30000 IU/day + vitamin C 500 mg/day), selective COX-2 inhibitor Celecoxib 200 mg/day.

Patients and Methods. 39 patients have been enrolled (18 head and neck, 7 lung, 4 breast, 3 pancreatic, 2 ovarian, 2 stomach, 1 uterine sarcoma, 1 kidney and 1 colorectal cancer; all stage IV).

The treatment is administered for 16 weeks. The following parameters have been evaluated: 1) clinical (stage and ECOG PS); 2) nutritional (Lean Body Mass, LBM, appetite and resting energy expenditure); 3) laboratory parameters (serum levels of proinflammatory cytokines and leptin, blood levels of reactive oxygen species (ROS) and antioxidant enzymes); 4) quality of life (EORTC QLQ- C30, EQ-5D and EQ-5D vas). 39 patients have been enrolled (18 head and neck, 7 lung, 4 breast, 3 pancreatic, 2 ovarian, 2 stomach, 1 uterine sarcoma, 1 kidney and 1 colorectal cancer; all stage IV).

Results. 39 patients are currently evaluable after 1 month of treatment, 32 after 2 months and 28 after 4 months. As for LBM a mean increase of 1.1 kgs (+3.7%, N.S.) after 1 month, 1.6 kgs (+7.0%, p=0.035) after 2 months and 1.9 kgs (+8.7%, p=0.049) after 4 months have been observed.

Appetite increased significantly after 1, 2 and 4 months of treatment. As for proinflammatory cytokines: IL-6 decreased significantly after 1 month, 2 months and 4 months of treatment; TNFalpha decreased significantly after 2 months and 4 months of treatment.

ROS and antioxidant enzyme GPx did not change significantly during treatment. The overall evaluation of QL showed a significant improvement of the EORTC QLQ-C30 and EQ-5D score after 1 month, 2 months and 4 months of treatment.

The evaluation of fatigue symptom by MSFI - SF showed a significant improvement after 1 month, 2 months and 4 months of treatment. The interim analysis on 28 patients who completed 4 months of treatment at November 2004 showed 15 responses (13 “responders” and 2 “high responders”).

Conclusion. According to the 2-stage Simon’s design criteria for Phase II studies the treatment is to be considered effective. Moreover, the treatment has demonstrated to be safe. The study is in progress to complete the evaluation period.

Work Supported by: Italian Ministry of University and Scientific Research, Rome, Italy: National Research Project No. 2004067078.

Abstract #5770 AACR 2005

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