Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-29 @ 6:18 AM
Study NCT ID:
NCT00878995
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2009-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA127971 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000629579 | None | None | View | |
| GCRC#724/819 | None | None | View |