Status:
COMPLETED
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cachexia
Squamous Cell Carcinoma
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief 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...
Detailed Description
OBJECTIVES: * To determine the effect of testosterone therapy on lean body mass and muscle strength in patients with advanced or recurrent squamous cell carcinoma. * To determine the testosterone the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00878995
Start Date
June 3 2009
End Date
June 1 2015
Last Update
March 12 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361