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Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

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ClinicalTrials.gov Identifier: NCT04049331
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : March 27, 2023
Sponsor:
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Study Description
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Brief Summary:
The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.

Condition or disease Intervention/treatment Phase
Hypogonadism, Male Fatigue Syndrome, Chronic Drug: Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] Other: placebo Phase 2

Detailed Description:

The overall goal of this proposal is to evaluate the efficacy of testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, quality of life, body composition, muscle strength and physical activity in a double-blind, randomized, placebo-controlled trial in young cancer survivors who report fatigue and have testosterone deficiency.

Fatigue is one of the most prevalent and debilitating symptoms in men with cancer affecting 70-100% of patients irrespective of their age. Cancer-related fatigue is experienced by patients not only during active cancer treatment, but is also highly prevalent in cancer survivors who exhibit persistent fatigue months to years after the end of their treatment with the highest prevalence being in recipients of chemotherapy and/or radiation therapy.

In addition to fatigue, sexual dysfunction is also highly prevalent in male cancer survivors. Male cancer survivors also have increased fat mass and decreased lean body mass, a phenotype that predisposes them to reduced muscle strength. This phenotype of fatigue, sexual dysfunction and adverse body composition is commonly encountered in non-cancer patient populations with testosterone deficiency, a condition which is also highly prevalent (50-90%) in cancer survivors. Pivotal trials of testosterone replacement therapy in non-cancer patient populations have shown an improvement in fatigue, sexual function and body composition in men randomized to testosterone compared with placebo. However, the efficacy of testosterone replacement therapy on cancer-related fatigue has not been studied.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : January 30, 2026
Estimated Study Completion Date : January 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Testosterone
Testosterone undecanoate injection 750 MG/3 ML
 Drug: Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]
first two doses four weeks apart; following three more doses every ten weeks.
Other Name: study drug
Placebo Comparator: Placebo
clinical grade saline 0.9% sodium chloride injection
 Other: placebo
first two doses four weeks apart; following three more doses every ten weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue change [ Time Frame: 9 months ]
    (Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) questionnaire


Secondary Outcome Measures :
  1. Sexual function change [ Time Frame: 9 months ]
    Harbor-UCLA 7-day Sexual Function Questionnaire

  2. Sexual function change [ Time Frame: 9 months ]
    International Index of Erective Function (IIEF) questionnaire

  3. Body composition change [ Time Frame: 9 months ]
    Lean body mass and fat mass (kg) measured by dual energy x-ray absorptiometry (DEXA)

  4. Changes to mood and well-being [ Time Frame: 9 months ]
    Mood and well-being will be assessed by the Positive and Negative Affect Scale (PANAS) affectivity balance scale, 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).

  5. Muscle strength change [ Time Frame: 9 months ]
    Maximal voluntary muscle strength in the lower extremities will be assessed by conducting the leg press exercise by the 1-repetition maximum method and assessing loaded stair climb power.

  6. Sleep quality change [ Time Frame: 9 months ]
    Pittsburgh Sleep Quality Index (PSQI)

  7. Sleep quality change [ Time Frame: 9 months ]
    Insomnia Severity Index (ISI)

  8. Sleep quality change [ Time Frame: 9 months ]
    Actigraphy

  9. Daily physical activity change [ Time Frame: 9 months ]
    Validated triaxial accelerometry (actigraphy)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year
  • Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias
  • Age: 18-54 years
  • 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 young men (age 19-40 years), is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone <348 ng/dl could be considered testosterone deficient. 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. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone <70 pg/mL.
  • Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40, which best divides cancer patients from the general population with 84% accuracy, and was used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).
  • Ability and willingness to provide informed consent.

Exclusion Criteria:

  • Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)
  • Men with brain cancer (potential cognitive impairment)
  • Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months
  • Appetite stimulating agents e.g. megestrol acetate within the past 6 months
  • Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months
  • Baseline hematocrit >48%
  • PSA >4 ng/ml in Caucasians; >3 ng/ml in African-Americans; nodule/induration on digital rectal exam
  • Men with 1st order relatives with a history of prostate cancer
  • Uncontrolled congestive heart failure
  • Severe untreated sleep apnea

  • Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months

    o Previous stroke with residual cognitive or functional deficits; Mini-Mental State Examination score <24

  • Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
  • Poorly controlled diabetes as defined by hemoglobin A1c >8.5%; Body mass index (BMI) >45 kg/m2
  • Untreated unipolar depression (treated depression with medications or counseling will be allowed
  • 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): NCT04049331


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

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Milena Braga, MD    617-525-9144    mbraga@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: Gary Miranda, LPN    206-277-6143    Gary.Miranda@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
Investigators
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Principal Investigator: Jose M Garcia, MD, PhD VA Puget Sound Health Care System
More Information
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Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT04049331    
Other Study ID Numbers: 01751
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
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.: No
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
testosterone
hypogonadism
cancer related fatigue
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Hypogonadism
Eunuchism
Fatigue
Gonadal Disorders
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Neuroinflammatory Diseases
Nervous System Diseases
Neuromuscular Diseases
 Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents