Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

NCT ID: NCT00878995

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-03
• Study Completion Date: 2015-06-30

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 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.

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 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.

Conditions

Cachexia; Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Standard of Care Therapy + Placebo Testosterone

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

Group Type: PLACEBO_COMPARATOR

Placebo Testosterone

Intervention Type: DRUG

Placebo (Saline) Testosterone given IM once per week.

Standard of Care Therapy + Testosterone

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

Group Type: ACTIVE_COMPARATOR

Testosterone Enanthate 100 MG/ML

Intervention Type: DRUG

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

Interventions

Placebo Testosterone

Placebo (Saline) Testosterone given IM once per week.

Intervention Type: DRUG

Testosterone Enanthate 100 MG/ML

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melinda Sheffield-Moore, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

References

Scott JM, Dillon EL, Kinsky M, Chamberlain A, McCammon S, Jupiter D, Willis M, Hatch S, Richardson G, Danesi C, Randolph K, Durham W, Wright T, Urban R, Sheffield-Moore M. Effects of adjunct testosterone on cardiac morphology and function in advanced cancers: an ancillary analysis of a randomized controlled trial. BMC Cancer. 2019 Aug 7;19(1):778. doi: 10.1186/s12885-019-6006-5.

Reference Type: DERIVED

PMID: 31391011 (View on PubMed)

Other Identifiers

R01CA127971

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000629579

Identifier Type: -

Identifier Source: secondary_id

GCRC#724/819

Identifier Type: -

Identifier Source: secondary_id

06-073/10-207

Identifier Type: -

Identifier Source: org_study_id