Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Squamous Cell Carcinoma; Cachexia

Treatments: Drug: Placebo Testosterone; Drug: Testosterone Enanthate 100 MG/ML

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00878995

06-073/10-207

CDR0000629579

R01CA127971 (U.S. NIH Grant/Contract)

GCRC#724/819

Details and patient eligibility

About

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.

Full 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 therapy on inflammatory biomarkers in patients with advanced or recurrent squamous cell carcinoma.

OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo testosterone intramuscularly (IM) weekly for 7 weeks.
• Arm II: Patients receive standard of care chemotherapy and/or radiation and testosterone IM weekly for 7 weeks.

Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope metabolic studies, indirect calorimetry studies, and assessment of their physical activity level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life questionnaires.

Blood, muscle tissue, and urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay.

After completion of study treatment, patients are followed periodically for 1 year.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Standard of Care Therapy + Placebo Testosterone

Placebo Comparator group

Description:

Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.

Treatment:

Drug: Placebo Testosterone

Standard of Care Therapy + Testosterone

Active Comparator group

Description:

Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks.

Treatment:

Drug: Testosterone Enanthate 100 MG/ML