RECRUITING

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency

Conditions

Hypogonadism, Male Cancer Fatigue testosterone cancer related fatigue active cancer hypogonadism

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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

This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.

Official Title

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency

Quick Facts

Study Start:2021-01-12

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04301765

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:55 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are \<60 months from their last treatment (chemotherapy and/or radiation therapy) will be included. * Age: 55 years and older * Life expectancy of at least 6 months. * 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 men is 348 ng/dL and the lower limits of free testosterone is \<70 pg/ml in the Framingham Heart Study sample. 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, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone \<70 pg/mL will be included. * Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of \<40, which best divides cancer patients from the general population with accuracy. * Ability and willingness to provide informed consent	* Men with current or prior history of prostate, breast, testicular, or adrenal cancers. * Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months * Hematocrit \>48%, serum creatinine \>2.5 mg/dL * PSA \>4 ng/ml; nodule or induration on digital rectal exam * Severe untreated sleep apnea * Uncontrolled congestive heart failure * Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months * Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden) * Previous stroke with residual cognitive or functional deficits * Inability to provide informed consent; MMSE score \<24 * Poorly controlled diabetes as defined by hemoglobin A1c \>10.0% * Body mass index (BMI) \>40 kg/m2 * Bipolar disorder or schizophrenia

Inclusion Criteria

Exclusion Criteria

* Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are \<60 months from their last treatment (chemotherapy and/or radiation therapy) will be included.
* Age: 55 years and older
* Life expectancy of at least 6 months.
* 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 men is 348 ng/dL and the lower limits of free testosterone is \<70 pg/ml in the Framingham Heart Study sample. 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, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone \<70 pg/mL will be included.
* Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of \<40, which best divides cancer patients from the general population with accuracy.
* Ability and willingness to provide informed consent

* Men with current or prior history of prostate, breast, testicular, or adrenal cancers.
* Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months
* Hematocrit \>48%, serum creatinine \>2.5 mg/dL
* PSA \>4 ng/ml; nodule or induration on digital rectal exam
* Severe untreated sleep apnea
* Uncontrolled congestive heart failure
* Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months
* Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden)
* Previous stroke with residual cognitive or functional deficits
* Inability to provide informed consent; MMSE score \<24
* Poorly controlled diabetes as defined by hemoglobin A1c \>10.0%
* Body mass index (BMI) \>40 kg/m2
* Bipolar disorder or schizophrenia

Contacts and Locations

Study Contact

Jose Garcia, MD, Phd

CONTACT

206 764 2984

jg77@uw.edu

Study Locations (Sites)

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912

United States

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

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 Date2021-01-12

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2021-01-12

Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

testosterone
cancer related fatigue
active cancer
hypogonadism

Additional Relevant MeSH Terms

Hypogonadism, Male
Cancer
Fatigue