Clinical trial NCT04301765: Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Official title: Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypogonadism, Male
Cancer
Fatigue
Keywords: testosterone
cancer related fatigue
active cancer
hypogonadism
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 230
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled, parallel group, trial of daily transdermal testosterone gel or placebo gel for 6-months
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The overall objective is to conduct a double-blind, randomized, placebo-controlled, parallel group trial to determine the efficacy of 6 months of physiological testosterone replacement therapy in improving cancer related fatigue, sexual dysfunction, and body composition and muscle function in men 55 years and older with solid or hematologic (blood) cancers, who report fatigue and have testosterone deficiency. There will be 5 study visits: 1) Screening, 2) Baseline, 3) 2-Week Dose Adjustment Visit, 4) Three-month visit (Week 12), and 5) Six-month visit. Testosterone or placebo gels will be applied by eligible trial participants at home; participants will be trained on gel application procedures by research personnel.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fatigue change
timeFrame: 6 months
Secondary outcomes:
measure: Change in Sexual Activity Score
timeFrame: 6 months
Other outcomes:
measure: Change in Other Measures of Sexual Function
timeFrame: 6 months
measure: Change in Mood and Well-being
timeFrame: 6 months
measure: Body Composition Changes
timeFrame: 6 months
measure: Muscle Strength Changes
timeFrame: 6 months
measure: Physical Function Changes
timeFrame: 6 months
measure: Objective Measures of Habitual Physical Activity Changes
timeFrame: 6 months
measure: Caregiver Burden Changes
timeFrame: 6 months
measure: Work Productivity
timeFrame: 6 months
measure: Sleep Quality Changes
timeFrame: 6 months
measure: Qualitative Survey
timeFrame: 6 months
Locations:
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Seattle
country: United States
facility: Veterans Affairs Puget Sound Health Care System
state: Washington
Study officials:
References: