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

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ClinicalTrials.gov Identifier: NCT04301765
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Jose Manuel Garcia, Seattle Institute for Biomedical and Clinical Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypogonadism, Male Cancer Fatigue Drug: testosterone 1.62% gel Other: placebo gel Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, placebo-controlled, parallel group, trial of daily transdermal testosterone gel or placebo gel for 6-months
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: testosterone 1.62% gel
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
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 Comparator: placebo gel
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue change [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in Sexual Activity Score [ Time Frame: 6 months ]
    Secondary outcome is change in sexual activity score, assessed by the Harbor-UCLA 7-day Sexual Function Questionnaire.


Other Outcome Measures:
  1. Change in Other Measures of Sexual Function [ Time Frame: 6 months ]
    Erectile function will be assessed by International Index of Erective Function (IIEF).

  2. Change in Mood and Well-being [ Time Frame: 6 months ]
    Mood and well-being will be assessed by Positive and Negative Affect Scale (PANAS), which includes 10 questions each for Positive Affect and Negative Affect. Many behavioral scientists consider affectivity as the cleanest window on an individual's wellbeing. The most sensitive indicator of impaired wellbeing has been shown to be affective dysregulation, which is reflected in affectivity balance. The latter incorporates negative affects (e.g., anxiety, depression) as well as positive affects (e.g., joy).

  3. Body Composition Changes [ Time Frame: 6 months ]
    Body composition changes will be assessed by measuring lean body mass and fat mass by dual energy X-ray absorptiometry (DEXA).

  4. Muscle Strength Changes [ Time Frame: 6 months ]
    Muscle strength will be assessed by measuring maximal voluntary strength in the leg press exercise by the 1-RM method.

  5. Physical Function Changes [ Time Frame: 6 months ]
    Physical function will be evaluated using the 6-minute walk test and will also be evaluated by measuring power in the lower extremities by conducting the leg press exercise.

  6. Objective Measures of Habitual Physical Activity Changes [ Time Frame: 6 months ]
    To determine changes in daily physical activity, validated actigraphy will be used.

  7. Caregiver Burden Changes [ Time Frame: 6 months ]
    The Brief Assessment Scale for Caregivers (BASC) will be used to determine caregiver burden.

  8. Work Productivity [ Time Frame: 6 months ]
    Loss of productivity will be evaluated using the Work Productivity and Impairment (WPAI) scale.

  9. Sleep Quality Changes [ Time Frame: 6 months ]
    Sleep quality will be assessed using the validated Pittsburgh Sleep Quality Index (PSQI) scale and by using actigraphy.

  10. Qualitative Survey [ Time Frame: 6 months ]
    Qualitative interviews will be performed by a study co-investigator which will assess lived experiences of participants at baseline and at 24 weeks by conducting semi-structured, qualitative phone interviews with a randomly selected sample of 30 men in the testosterone arm and 30 men in the placebo arm (equally divided across the 3 sites).


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301765


Contacts
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Contact: Jose Garcia, MD, Phd 206 764 2984 jg77@uw.edu

Locations
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United States, Georgia
Georgia Cancer Center at Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Egidio Del Fabbro, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Milena Braga, MD    617-525-9144    mbraga2@bwh.harvard.edu   
Principal Investigator: Shehzad Basaria, MD         
United States, Washington
Veterans Affairs Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Haley Lowe, RN, MN    206-277-4253    Haley.Lowe@va.gov   
Contact: Lindsey Anderson, PhD    2062776719    Lindsey.Anderson5@va.gov   
Principal Investigator: Jose M Garcia, MD, PhD         
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
More Information
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Responsible Party: Jose Manuel Garcia, Principal Investigator, Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT04301765    
Other Study ID Numbers: AG061558
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jose Manuel Garcia, Seattle Institute for Biomedical and Clinical Research:
testosterone
cancer related fatigue
active cancer
hypogonadism
Additional relevant MeSH terms:
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Hypogonadism
Eunuchism
Fatigue
Gonadal Disorders
Endocrine System Diseases
 Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs