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Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00878995
First received: April 8, 2009
Last updated: January 12, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Cachexia
Squamous Cell Carcinoma
Drug: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
Drug: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nutrition and Anabolic Interventions in Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Total lean body mass and regional muscle mass as measured by dual energy x-ray absorptiometry (DEXA) at baseline and 7 weeks. [ Time Frame: Baseline and 7 weeks ]
  • Muscle strength and fatigue tests, including tests of maximal voluntary contraction (isometric and isokinetic leg strength on Biodex) at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ]
  • Changes in serum inflammatory biomarkers and muscle inflammatory cytokines as measured by immunoassay at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ]
  • Changes in NF-kB expression as measured by western analysis at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ]

Secondary Outcome Measures:
  • Changes in body weight and fat mass as measured by DEXA at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ]
  • Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations [ Time Frame: Baseline and 7 weeks ]
  • Quality of Life Measurements. [ Time Frame: Weekly ]
    Mood, fatigue, and quality of life as measured by the Medical Outcome Study-Short Form - 36 items (MOS-SF-36), the FACT-G, the Multidimensional Fatigue Symptom Inventory, the Profile of Mood States-Short Form (POMS-SF), the MD Anderson Symptom Inventory (MDASI), and the MD Anderson Brief Fatigue Inventory questionnaires

  • Physical activity levels, intensities, and energy expenditure as measured by the ActiGraph accelerometer (worn on the hip or ankle) [ Time Frame: Daily ]
  • 1-year survival [ Time Frame: monthly ]

Enrollment: 29
Study Start Date: April 2008
Study Completion Date: June 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I: Standard of Care Therapy + Placebo Testosterone
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Drug: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
Active Comparator: Arm II: Standard of Care Therapy + Testosterone
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Drug: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878995

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Cancer Institute (NCI)
Investigators
Principal Investigator: Melinda Sheffield-Moore, PhD University of Texas
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00878995     History of Changes
Other Study ID Numbers: 06-073/10-207  R01CA127971  CDR0000629579  GCRC#724/819 
Study First Received: April 8, 2009
Last Updated: January 12, 2017

Keywords provided by The University of Texas Medical Branch, Galveston:
stage IIB cervical cancer
stage III cervical cancer
recurrent cervical cancer
cachexia
advanced head/neck carcinoma
recurrent head/neck carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Cachexia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Antineoplastic Agents
Methyltestosterone
Testosterone enanthate
Testosterone
Testosterone undecanoate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Anabolic Agents

ClinicalTrials.gov processed this record on March 01, 2017