Trial Outcomes & Findings for Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients (NCT NCT00965341)

Last Updated: 2016-09-13

Results Overview

The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

53 participants

Primary outcome timeframe

Day 29 (+/- 3 days)

Results posted on

2016-09-13

Participant Flow

Clinic outpatients with advanced cancer were recruited from September 2009 to November 2011 at both Michael E. DeBakey Veterans Affairs Medical Center (VA) and University of Texas MD Anderson Cancer Center (MDACC).

Of the 53 participants enrolled only 43 subjects met eligibility criteria. Ten participants either did not meet criteria or withdrew consent prior to assignment to groups.

Participant milestones

Participant milestones
Measure	Testosterone Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.	Placebo Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
Overall Study STARTED	19	24
Overall Study COMPLETED	13	16
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Testosterone Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.	Placebo Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
Overall Study Withdrew consent	1	5
Overall Study Lost to Follow-up	1	0
Overall Study Transportation issues	4	3

Baseline Characteristics

Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone n=19 Participants Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.	Placebo n=24 Participants Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants	11 Participants n=107 Participants	23 Participants n=206 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants	13 Participants n=107 Participants	20 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	19 Participants n=99 Participants	24 Participants n=107 Participants	43 Participants n=206 Participants
Region of Enrollment United States	19 participants n=99 Participants	24 participants n=107 Participants	43 participants n=206 Participants

PRIMARY outcome

Timeframe: Day 29 (+/- 3 days)

Outcome measures

Outcome measures
Measure	Testosterone n=13 Participants Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.	Placebo n=16 Participants Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days) FACIT-F Total Score (29 days-baseline)	12 units on a scale Standard Deviation 13.8	13 units on a scale Standard Deviation 19.3
Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days) FACIT-F Fatigue Subscale (29 days-baseline)	12 units on a scale Standard Deviation 7.7	14 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: Day 29 (+/- 3 days)

The ESAS assessed 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0-10 (0 = no symptom, 10 = worst possible severity). Depression was assessed using the 14-item HADS questionnaire. Each item on the questionnaire was scored from 0-3. Total Scores for the HADS Questionnaire range from 0 to 42 with higher scores denoting feeling of depression.

Outcome measures

Outcome measures
Measure	Testosterone n=13 Participants Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.	Placebo n=16 Participants Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Anxiety, ESAS	7 units on a scale Standard Deviation 3	5 units on a scale Standard Deviation 2
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Depression, HADS	7 units on a scale Standard Deviation 3	6 units on a scale Standard Deviation 3
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Well being, ESAS	5 units on a scale Standard Deviation 3	3 units on a scale Standard Deviation 3
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Sleep, ESAS	5 units on a scale Standard Deviation 2	4 units on a scale Standard Deviation 2
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Appetite, ESAS	5 units on a scale Standard Deviation 3	4 units on a scale Standard Deviation 3
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Dyspnea, ESAS	2 units on a scale Standard Deviation 3	3 units on a scale Standard Deviation 2
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Drowsiness, ESAS	5 units on a scale Standard Deviation 3	4 units on a scale Standard Deviation 2
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Nausea, ESAS	2 units on a scale Standard Deviation 2	2 units on a scale Standard Deviation 3
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Fatigue, ESAS	6 units on a scale Standard Deviation 2	6 units on a scale Standard Deviation 2
The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS). Pain, ESAS	3 units on a scale Standard Deviation 2	3 units on a scale Standard Deviation 2

Adverse Events

Testosterone

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Testosterone n=19 participants at risk Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.	Placebo n=24 participants at risk Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
General disorders Death	5.3% 1/19 • Number of events 1 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	0.00% 0/24 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.

Other adverse events

Other adverse events
Measure	Testosterone n=19 participants at risk Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.	Placebo n=24 participants at risk Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
General disorders Fatigue	10.5% 2/19 • Number of events 2 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	12.5% 3/24 • Number of events 3 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Pain (NOS)	10.5% 2/19 • Number of events 2 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	4.2% 1/24 • Number of events 1 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Anorexia	10.5% 2/19 • Number of events 2 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	8.3% 2/24 • Number of events 2 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Dyspnea	0.00% 0/19 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	12.5% 3/24 • Number of events 3 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Neuropathy: Sensory	10.5% 2/19 • Number of events 2 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	0.00% 0/24 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Hemoglobin	5.3% 1/19 • Number of events 1 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	0.00% 0/24 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Infection (Other)	5.3% 1/19 • Number of events 1 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	0.00% 0/24 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Neuropathy: Cranial	5.3% 1/19 • Number of events 1 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	0.00% 0/24 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Pain (Other)	5.3% 1/19 • Number of events 1 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	0.00% 0/24 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.
General disorders Pain (Skin)	5.3% 1/19 • Number of events 1 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.	0.00% 0/24 • Adverse events were collected from baseline through day 57 and 30 days after the last study drug injection.

Additional Information

Rony Dev, DO / Assistant Professor

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-745-4192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place