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Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer

2014-08-27 03:54:53 | BioPortfolio

Summary

RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.

PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.

Description

OBJECTIVES:

- Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol.

- Compare the health-related quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-III vs IV), concurrent radiotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral oxandrolone twice daily.

- Arm II: Patients receive oral megestrol once daily. In both arms, treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity.

Quality of life, weight, and body composition are assessed at baseline, at 1, 2, and 3 months during study therapy, and then at 1 month after study completion.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 62-155 patients (31-77 per treatment arm) will be accrued for this study within 2 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Supportive Care

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

megestrol acetate, oxandrolone, quality-of-life assessment

Location

Helen F. Graham Cancer Center at Christiana Care
Newark
Delaware
United States
19713

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:53-0400

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