RECRUITING

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

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Conditions

Hypogonadism, MaleFatigue Syndrome, Chronictestosteronehypogonadismcancer related fatigue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.

Official Title

Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer

Quick Facts

Study Start:2021-03-22
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04049331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 54 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year
  2. * Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias
  3. * Age: 18-54 years
  4. * Serum testosterone, measured by mass spectrometry (gold standard method), of \<348 ng/dl and/or free testosterone \<70 pg/ml. The lower limits of the normal range for total testosterone in healthy young men (age 19-40 years), is 348 ng/dL and the lower limits of free testosterone is \<70 pg/ml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone \<348 ng/dl could be considered testosterone deficient. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone \<70 pg/mL.
  5. * Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of \<40, which best divides cancer patients from the general population with 84% accuracy, and was used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).
  6. * Ability and willingness to provide informed consent.
  1. * Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)
  2. * Men with brain cancer (potential cognitive impairment)
  3. * Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months
  4. * Appetite stimulating agents e.g. megestrol acetate within the past 6 months
  5. * Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months
  6. * Baseline hematocrit \>48%
  7. * PSA \>4 ng/ml in Caucasians; \>3 ng/ml in African-Americans
  8. * Men with 1st order relatives with a history of prostate cancer
  9. * Uncontrolled congestive heart failure
  10. * Severe untreated sleep apnea
  11. * Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
  12. * Serum creatinine \>2.5 mg/dL; ALT 3x upper limit of normal
  13. * Poorly controlled diabetes as defined by hemoglobin A1c \>8.5%; Body mass index (BMI) \>45 kg/m2
  14. * Untreated unipolar depression (treated depression with medications or counseling will be allowed
  15. * Bipolar disorder or schizophrenia

Contacts and Locations

Study Contact

Jose M Garcia, MD, PhD
CONTACT
206 764 2984
jg77@uw.edu

Principal Investigator

Jose M Garcia, MD, PhD
PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, 98108
United States

Collaborators and Investigators

Sponsor: Seattle Institute for Biomedical and Clinical Research

  • Jose M Garcia, MD, PhD, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-22
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2021-03-22
Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

  • testosterone
  • hypogonadism
  • cancer related fatigue

Additional Relevant MeSH Terms

  • Hypogonadism, Male
  • Fatigue Syndrome, Chronic