MedTrace Logo

Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

NCT00878995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-03-12

Study results available
· View outcomes & findings →

Summary

RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in patients with cachexia caused by cancer.

PURPOSE: This randomized phase I trial is studying whether testosterone administered during standard of care chemotherapy and/or radiation works by helping patients with squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.

Conditions

Interventions

DRUG

Placebo Testosterone

Placebo (Saline) Testosterone given IM once per week.

DRUG

Testosterone Enanthate 100 MG/ML

Testosterone Enanthate 100mg/ml given once per week IM.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Melinda Sheffield-Moore, PhD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-03
Primary Completion
2014-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00878995 on ClinicalTrials.gov