Trial · NCT00878995

Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

NCT00878995, Phase 1, Completed, The University of Texas Medical Branch, Galveston; results first posted 2018-03-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma. Trials, record NCT00878995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00878995

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
NCT number: NCT00878995
Status: Completed
Phases: Phase 1
Enrollment: 28 participants, actual
Lead sponsor: The University of Texas Medical Branch, Galveston
Conditions: Cachexia, Squamous Cell Carcinoma
Interventions: Placebo Testosterone, Testosterone Enanthate 100 MG/ML
First posted: 2009-04-09
Last updated: 2018-03-12
Results first posted: 2018-03-12

Source ClinicalTrials.gov

Registered outcomes47

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.	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.
Secondary	Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline	Baseline	Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.
Secondary	Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.	7 weeks	Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.
Secondary	Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.	Baseline	Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.
Secondary	Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks	7 weeks	Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.
Secondary	Body Weight as Measured by Scale at Baseline	Baseline	Body weight in kilograms as measured by a scale at the baseline visit.
Secondary	Body Weight as Measured by Scale at 7 Weeks.	7 weeks	Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.
Secondary	Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline	Baseline	Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
Secondary	Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks	7 weeks	Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
Secondary	Physical Activity Levels as Measured by the ActiGraph Accelerometer	through study completion,up to 7 weeks	Physical activity is reported as % time sedentary for the entire 7 week study.

1 to 10 of 47Source ClinicalTrials.gov

See all 47 registered outcomes

Outcomes47

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.	7 weeks	Reporting data for the 22 completing subjects only, since this data is reported as change over time.	Percent change	MEAN
SECONDARY	Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline	Baseline	24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.	Newton-Meters	MEAN
SECONDARY	Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.	7 weeks	Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.	Newton-Meters	MEAN
SECONDARY	Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.	Baseline	24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.	Watts	MEAN
SECONDARY	Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks	7 weeks	Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.	Watts	MEAN
SECONDARY	Body Weight as Measured by Scale at Baseline	Baseline	24 subjects began the study. Each subjects was able to complete this outcome measure at the baseline time point.	Kilograms	MEAN
SECONDARY	Body Weight as Measured by Scale at 7 Weeks.	7 weeks	22 subjects completed this outcome measure at the 7 week time point. 24 subjects started the study, 2 subjects dis-enrolled after the baseline visit.	Kilograms	MEAN
SECONDARY	Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline	Baseline	24 subjects completed this outcome measure at the baseline visit.	kilo-calories per day	MEAN
SECONDARY	Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks	7 weeks	Only 19 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.	kilo-calories per day	MEAN
SECONDARY	Physical Activity Levels as Measured by the ActiGraph Accelerometer	through study completion,up to 7 weeks	Data from only 12 subjects is presented due to a compliance issue with wearing the activity monitoring belts. A threshold was set to determine if subject was wearing the belt as directed.	% time sedentary	MEAN

1 to 10 of 47Source ClinicalTrials.gov

See all 47 outcomes

Results by group94

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.	Arm I: Standard of Care Therapy + Placebo Testosterone	-3.31	Standard Deviation 6.34	Percent change
Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.	Arm II: Standard of Care Therapy + Testosterone	1.42	Standard Deviation 7.25	Percent change
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline	Arm I: Standard of Care Therapy + Placebo Testosterone	81.77	Standard Deviation 42.58	Newton-Meters
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline	Arm II: Standard of Care Therapy + Testosterone	122.50	Standard Deviation 70.78	Newton-Meters
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.	Arm I: Standard of Care Therapy + Placebo Testosterone	76.75	Standard Deviation 25.22	Newton-Meters
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.	Arm II: Standard of Care Therapy + Testosterone	118.26	Standard Deviation 62.26	Newton-Meters
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.	Arm I: Standard of Care Therapy + Placebo Testosterone	137.60	Standard Deviation 86.77	Watts
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.	Arm II: Standard of Care Therapy + Testosterone	169.0	Standard Deviation 99.71	Watts
Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks	Arm I: Standard of Care Therapy + Placebo Testosterone	126.93	Standard Deviation 57.05	Watts
Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks	Arm II: Standard of Care Therapy + Testosterone	157.90	Standard Deviation 84.49	Watts

1 to 10 of 94Source ClinicalTrials.gov

See all 94 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Baseline Study - Midpoint Study	STARTED	Arm I: Standard of Care Therapy + Placebo Testosterone	12
Baseline Study - Midpoint Study	STARTED	Arm II: Standard of Care Therapy + Testosterone	12
Baseline Study - Midpoint Study	Baseline Study	Arm I: Standard of Care Therapy + Placebo Testosterone	12
Baseline Study - Midpoint Study	Baseline Study	Arm II: Standard of Care Therapy + Testosterone	12
Baseline Study - Midpoint Study	COMPLETED	Arm I: Standard of Care Therapy + Placebo Testosterone	12
Baseline Study - Midpoint Study	COMPLETED	Arm II: Standard of Care Therapy + Testosterone	10
Baseline Study - Midpoint Study	NOT COMPLETED	Arm I: Standard of Care Therapy + Placebo Testosterone	0
Baseline Study - Midpoint Study	NOT COMPLETED	Arm II: Standard of Care Therapy + Testosterone	2
Midpoint Study - Post Study	STARTED	Arm I: Standard of Care Therapy + Placebo Testosterone	12
Midpoint Study - Post Study	STARTED	Arm II: Standard of Care Therapy + Testosterone	10

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dysphagia	General disorders	Arm I: Standard of Care Therapy + Placebo Testosterone	1	12	1
other	Dysphagia	General disorders	Arm II: Standard of Care Therapy + Testosterone	0	12	0
other	Fever	Infections and infestations	Arm I: Standard of Care Therapy + Placebo Testosterone	2	12	2
other	Fever	Infections and infestations	Arm II: Standard of Care Therapy + Testosterone	0	12	0
other	Neutropenic Fever	Infections and infestations	Arm I: Standard of Care Therapy + Placebo Testosterone	0	12	0
other	Neutropenic Fever	Infections and infestations	Arm II: Standard of Care Therapy + Testosterone	1	12	1
other	Urinary Tract Infection	Renal and urinary disorders	Arm I: Standard of Care Therapy + Placebo Testosterone	4	12	5
other	Urinary Tract Infection	Renal and urinary disorders	Arm II: Standard of Care Therapy + Testosterone	2	12	2
other	Thrombocytosis	Blood and lymphatic system disorders	Arm I: Standard of Care Therapy + Placebo Testosterone	1	12	1
other	Thrombocytosis	Blood and lymphatic system disorders	Arm II: Standard of Care Therapy + Testosterone	0	12	0

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I: Standard of Care Therapy + Placebo Testosterone	0	12
Total, all-cause mortality	Arm II: Standard of Care Therapy + Testosterone	0	12
Total, other adverse events	Arm I: Standard of Care Therapy + Placebo Testosterone	6	12
Total, other adverse events	Arm II: Standard of Care Therapy + Testosterone	3	12
Total, serious adverse events	Arm I: Standard of Care Therapy + Placebo Testosterone	6	12
Total, serious adverse events	Arm II: Standard of Care Therapy + Testosterone	6	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31391011	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01CA127971	Nutrition and Anabolic Interventions in Cancer Cachexia	SHEFFIELD-MOORE, MELINDA	UNIVERSITY OF TEXAS MED BR GALVESTON	NATIONAL CANCER INSTITUTE	2008 to 2014

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I: Standard of Care Therapy + Placebo Testosterone vs Arm II: Standard of Care Therapy + Testosterone: 1-year Survival	Trial comparisons
Arm I: Standard of Care Therapy + Placebo Testosterone vs Arm II: Standard of Care Therapy + Testosterone: deaths from any cause	Trial comparisons
Arm I: Standard of Care Therapy + Placebo Testosterone vs Arm II: Standard of Care Therapy + Testosterone: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00878995

GET https://conductscience.org/api/trials/v1/NCT00878995/registered?page=2

API reference For AI assistants