CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Placebo Testosterone +1 moredrug
Likely dose
Testosterone Enanthate 100 MG/MLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00878995
NCT00878995Phase 1Completed
CompareCT.gov

Nutrition and Anabolic Interventions in Squamous Cell Carcinoma

The University of Texas Medical Branch, Galveston·interventional·Posted Apr 9, 2009·Updated Mar 12, 2018

In Brief

A Phase 1 clinical trial evaluating Placebo Testosterone and Testosterone Enanthate 100 MG/ML for Cachexia and Squamous Cell Carcinoma. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCachexia, Squamous Cell Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2009
Enrollment StartJun 3, 2009
Primary CompletionJun 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 17.2 years ago

Interventions

Placebo Testosteronedrug

Placebo (Saline) Testosterone given IM once per week.

Testosterone Enanthate 100 MG/MLdrug

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