Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antineoplastic Agents; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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