Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

Completed · Phase 1 · Has a placebo group

Conditions studied: Cachexia, Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00878995

Run by

The University of Texas Medical Branch, Galveston

People needed

28

Starts

2009-06-03

Expected to finish

2015-06-01

Last updated by the study team

2018-03-12

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Mini Mental State Examination score > 23

You may not qualify if…

• Pregnancy
• Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes
• Significant liver, renal, or heart disease
• Diabetes mellitus or other untreated endocrine disease
• Polycystic ovary syndrome and/or hyperthecosis
• Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g., Sertoli- Leydig cell tumor)
• Non-classical adrenal hyperplasia
• Cushing's syndrome
• Glucocorticoid resistance
• Hyperprolactinoma or hypothyroidism
• Lactose intolerance
• Alcohol or drug abuse
• Recent treatment (within 3 months) with anabolic steroids
• Ongoing anticoagulant therapy
• Any other circumstance that would preclude study participation, in the opinion of the principal investigator or study physician

Where it is running

• University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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