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

NCT04301765 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AG061558
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hypogonadism, Male; Cancer; Fatigue

Keywords

testosterone; cancer related fatigue; active cancer; hypogonadism

Outcome Measures

Primary Outcomes (1)

• Fatigue change

  Primary outcome is change in fatigue score. Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-Fatigue)- The FACIT-Fatigue has been widely used in studies related to cancer-related fatigue and is able to detect clinically meaningful differences in fatigue scores in response to treatment. Population norms for the FACIT are also available, facilitating the interpretation of fatigue levels in patient populations. This instrument has been well-validated, is responsive to treatment and more sensitive to change in fatigue than other instruments. Score range: 0-52, the higher the score the better quality of life.

  6 months

Secondary Outcomes (1)

• Change in Sexual Activity Score

  6 months

Other Outcomes (10)

• Change in Other Measures of Sexual Function

  6 months

• Change in Mood and Well-being

  6 months

• Body Composition Changes

  6 months

Study Arms (2)

testosterone 1.62% gel

EXPERIMENTAL

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.

Drug: testosterone 1.62% gel

placebo gel

PLACEBO COMPARATOR

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.

Other: placebo gel

Interventions

testosterone 1.62% gel DRUG

The 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

testosterone 1.62% gel

placebo gel OTHER

The 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

placebo gel

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead

Study Sites (3)

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

Eunuchism; Neoplasms; Fatigue; Hypogonadism

Interventions

Testosterone; Gels

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Jose Garcia, MD, Phd

CONTACT

206 764 2984; jg77@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, double-blind, placebo-controlled, parallel group, trial of daily transdermal testosterone gel or placebo gel for 6-months

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 10, 2020
• Study Start: January 12, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)