22 Nov Testosterone in Men with Cancer (TEMEC)
The Testosterone in Men with Cancer study is a research study in men, ages 55 and older, who have solid or hematologic (blood) cancer and have received, or are receiving, chemotherapy and/or radiation for their cancer in the past 5 years. The purpose of the study is to evaluate whether testosterone gel compared to placebo gel improves fatigue, sexual function, quality of life, muscle mass, muscle strength, and physical activity in men with cancer who report fatigue and have low testosterone. Cancer-related fatigue affects 70%-100% of all cancer patients. Decreased energy, sexual dysfunction, and decreased muscle mass are known consequences of low testosterone. These same symptoms are also commonly reported in cancer patients.
If you would like to participate, you will receive a health screening evaluation and some blood tests to see if you qualify for the study. If you are found eligible and agree to enroll in the study, you will be asked to attend 4 study visits at the Seattle VA Hospital over a period of 6 months. At these visits, you will undergo various study procedures including: blood draw, physical exam, questionnaires, physical function tests, body imaging, and general questions about your health. You will receive either a testosterone gel or a placebo gel (a gel with no medicine in it) which will be applied once daily. Your health will be closely monitored by study clinicians. You will be financially compensated for each study visit you complete and the total compensation for the completion of all study visits is $480.
Participant Eligibility
– Male– Age 55 years and older– Solid or hematologic (blood) cancer diagnosis– Currently receiving or received chemotherapy and/or radiation therapy for your cancer treatment in the last 5 years– Have never been diagnosed with breast, prostate, testicular, or adrenal cancer– Have not been treated with testosterone, DHEA, or growth hormone in the past 6 months-Have not had any of these health issues within the past 6 months: myocardial infarction, acute coronary syndrome, revascularization surgery, stroke, or thromboembolism– Have not been diagnosed with bipolar disorder or schizophrenia-Do not have uncontrolled congestive heart failure or untreated severe sleep apnea
Contact
Haley Lowe
(206) 277-4253
Additional Study Details
Full Study Title
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men with Cancer and Androgen Deficiency
Investigator(s)
Jose Garcia, MD, Professor, University of Washington, Department of Medicine (Principal Investigator)
Stacey Cohen, MD, Associate Professor, University of Washington, Department of Medicine
Accepts Healthy Volunteers?
No
Study Site(s)
Veterans Affairs Puget Sound Health Care System
1660 South Columbian Way
Seattle, Washington 98108
