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Testosterone Gel for Cancer-Related Fatigue (TEMEC Trial)
Phase 2
Recruiting
Research Sponsored by Seattle Institute for Biomedical and Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 55 years and older
Life expectancy of at least 6 months.
Timeline
Screening 1 day
Treatment 6 months
Follow Up 0 days
Summary
This trial is testing whether testosterone replacement can help with cancer-related fatigue in older men who have low testosterone levels.
Who is the study for?
Men aged 55+ with incurable lung or colorectal cancer, experiencing fatigue and low testosterone levels after chemo/radiation therapy. They should have a life expectancy of at least 6 months, not be severely ill from other conditions, and must consent to participate.
What is being tested?
The trial is testing if testosterone gel improves fatigue in older men with cancer compared to a placebo. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real treatment until the end.
What are the potential side effects?
Possible side effects include skin irritation where the gel is applied, changes in mood or energy levels, increased red blood cell count which can thicken blood, and potential impacts on prostate health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Select...
You are expected to live for at least 6 more months.
Select...
My testosterone levels are low, below the normal range.
Timeline
Screening ~ 1 day0 visits
Treatment ~ 6 months4 visits
Follow Up ~ 0 days0 visits
Screening ~ 1 day
Treatment ~ 6 months
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fatigue change
Secondary study objectives
Change in Sexual Activity Score
Other study objectives
Body Composition Changes
Caregiver Burden Changes
Change in Mood and Well-being
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: testosterone 1.62% gelExperimental Treatment1 Intervention
Testosterone 1.62% gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.
Group II: placebo gelPlacebo Group1 Intervention
The placebo gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.
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Who is running the clinical trial?
Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
53 Previous Clinical Trials
13,431 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition that causes blood clots.I am not taking any glucocorticoids, except as part of chemotherapy.I often feel very tired, more than usual.I am a man with a history of hormone-dependent cancer.My PSA level is above 4, or I have a nodule found during a rectal exam.I haven't taken appetite stimulants like megestrol in the last month.I haven't had a heart attack, stroke, or any related surgery in the last 6 months.I am a man with lung or colorectal cancer, treated with chemo or radiation, and have been NED for less than 24 months.My testosterone levels are low, below the normal range.I have had a stroke that left me with thinking or physical difficulties.I am a man with cancer that has spread to my brain.You have been diagnosed with bipolar disorder or schizophrenia.You are expected to live for at least 6 more months.I am 55 years old or older.I have heart failure that is not well-managed.I have severe sleep apnea that hasn't been treated.I am 55 years old or older.I have not used any anabolic agents like testosterone in the last 6 months.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: testosterone 1.62% gel
- Group 2: placebo gel
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
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