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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

Tracking Information
First Submitted Date  ICMJE March 3, 2020
First Posted Date  ICMJE March 10, 2020
Last Update Posted Date February 7, 2024
Actual Study Start Date  ICMJE January 12, 2021
Estimated Primary Completion Date January 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2024)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2020)		 Fatigue change [ Time Frame: 6 monthas ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2020)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 5, 2024)
  • Change in Other Measures of Sexual Function [ Time Frame: 6 months ]
    Erectile function will be assessed by International Index of Erective Function (IIEF).
  • 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).
  • 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).
  • 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.
  • 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.
  • Objective Measures of Habitual Physical Activity Changes [ Time Frame: 6 months ]
    To determine changes in daily physical activity, validated actigraphy will be used.
  • Caregiver Burden Changes [ Time Frame: 6 months ]
    The Brief Assessment Scale for Caregivers (BASC) will be used to determine caregiver burden.
  • Work Productivity [ Time Frame: 6 months ]
    Loss of productivity will be evaluated using the Work Productivity and Impairment (WPAI) scale.
  • 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.
  • 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).
Original Other Pre-specified Outcome Measures
 (submitted: March 5, 2020)
  • Change in Other Measures of Sexual Function [ Time Frame: 6 months ]
    Erectile function will be assessed by International Index of Erective Function (IIEF).
  • Change in Mood and Well-being [ Time Frame: 6 months ]
    Mood and well-being will be assessed by Positive and Negative Affect Scale (PANAS).
  • 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).
  • 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;
  • Physical Function Changes [ Time Frame: 6 months ]
    physical function will be evaluated using the 6-minute walk test andwill also be evaluated by measuring power in the lower extremities by conducting the leg press exercise
  • Objective Measures of Habitual Physical Activity Changes [ Time Frame: 6 months ]
    To determine changes in daily physical activity, validated actigraphy will be used.
  • Caregiver Burden Changes [ Time Frame: 6 months ]
    The Brief Assessment Scale for Caregivers (BASC) will be used to determine caregiver burden.
  • Work Productivity [ Time Frame: 6 months ]
    Loss of productivity will be evaluated using the Work Productivity and Impairment (WPAI) scale.
  • 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
  • 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).
 
Descriptive Information
Brief Title  ICMJE Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Official Title  ICMJE Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Hypogonadism, Male
  • Cancer
  • Fatigue
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: testosterone 1.62% gel
  • 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.
    Intervention: Other: placebo gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2020)		 230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2026
Estimated Primary Completion Date January 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Garcia, MD, Phd 206 764 2984 jg77@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04301765
Other Study ID Numbers  ICMJE AG061558
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jose Manuel Garcia, Seattle Institute for Biomedical and Clinical Research
Original Responsible Party Jose Manuel Garcia, Seattle Institute for Biomedical and Clinical Research, MD, PhD
Current Study Sponsor  ICMJE Seattle Institute for Biomedical and Clinical Research
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seattle Institute for Biomedical and Clinical Research
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP