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

NCT00070148 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2021-09-09

No results posted yet for this study

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.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Weight Changes

Interventions

DRUG

Megestrol Acetate

Megace by mouth for 12 weeks

DRUG

Oxandrolone 20 mg

20 mg/day for 3 months (12 weeks)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Edward G. Shaw, MD · Wake Forest University Health Sciences

  • Glenn J. Lesser, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-01
Primary Completion
2007-08-01
Completion
2007-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00070148 on ClinicalTrials.gov