Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

NCT00878995 | Completed Phase 1 Results

• 4 other identifiers: 06-073/10-207R01CA127971CDR0000629579GCRC#724/819
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cachexia; Squamous Cell Carcinoma

Keywords

stage IIB cervical cancer; stage III cervical cancer; recurrent cervical cancer; cachexia; advanced head/neck carcinoma; recurrent head/neck carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.

  Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.

  7 weeks

Secondary Outcomes (46)

• Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline

  Baseline

• Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.

  7 weeks

• Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.

  Baseline

• Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks

  7 weeks

• Body Weight as Measured by Scale at Baseline

  Baseline

Study Arms (2)

Standard of Care Therapy + Placebo Testosterone

PLACEBO COMPARATOR

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

Drug: Placebo Testosterone

Standard of Care Therapy + Testosterone

ACTIVE COMPARATOR

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

Drug: Testosterone Enanthate 100 MG/ML

Interventions

Placebo Testosterone DRUG

Placebo (Saline) Testosterone given IM once per week.

Standard of Care Therapy + Placebo Testosterone

Testosterone Enanthate 100 MG/ML DRUG

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

Standard of Care Therapy + Testosterone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

Related Publications (1)

• 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.

  PMID: 31391011 DERIVED

MeSH Terms

Conditions

Cachexia; Carcinoma, Squamous Cell; Uterine Cervical Neoplasms

Interventions

testosterone enanthate

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Melinda Sheffield-Moore
• Organization: University of Texas Medical Branch

melmoore@utmb.edu

409-772-8707

Study Officials

• Melinda Sheffield-Moore, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: June 3, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 12, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-03

Locations

US (1)