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

Primary Purpose

Hypogonadism, Male, Cancer, Fatigue

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
testosterone 1.62% gel
placebo gel
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypogonadism, Male focused on measuring testosterone, cancer related fatigue, active cancer, hypogonadism

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men with active lung or colorectal cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 24 months or less, which means that they are <24 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 hormone-dependent cancers (breast, prostate)
  • Men with brain metastases from any type of cancer
  • Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months
  • Current use of systemic glucocorticoids (unless part of the chemotherapy regimen)
  • Appetite stimulating agents (e.g. megestrol acetate) within the past 1 month
  • Hematocrit >48%, serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
  • 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 >8.5%
  • Body mass index (BMI) >40 kg/m2
  • Untreated unipolar depression (treated depression is allowed)
  • Bipolar disorder or schizophrenia

Sites / Locations

  • Georgia Cancer Center at Augusta UniversityRecruiting
  • Brigham and Women's HospitalRecruiting
  • Veterans Affairs Puget Sound Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

testosterone 1.62% gel

placebo gel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Sexual Activity Score
Secondary outcome is change in sexual activity score, assessed by the Harbor-UCLA 7-day Sexual Function Questionnaire.

Full Information

First Posted
March 3, 2020
Last Updated
March 22, 2023
Sponsor
Seattle Institute for Biomedical and Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT04301765
Brief Title
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Acronym
TEMEC
Official Title
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 incurable 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 active lung or colorectal 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Male, Cancer, Fatigue
Keywords
testosterone, cancer related fatigue, active cancer, hypogonadism

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled, parallel group, trial of daily transdermal testosterone gel or placebo gel for 6-months
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
testosterone 1.62% gel
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo gel
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
testosterone 1.62% gel
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
placebo gel
Intervention Description
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
Primary Outcome Measure Information:
Title
Fatigue change
Description
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.
Time Frame
6 monthas
Secondary Outcome Measure Information:
Title
Change in Sexual Activity Score
Description
Secondary outcome is change in sexual activity score, assessed by the Harbor-UCLA 7-day Sexual Function Questionnaire.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in Other Measures of Sexual Function
Description
Erectile function will be assessed by International Index of Erective Function (IIEF).
Time Frame
6 months
Title
Change in Mood and Well-being
Description
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).
Time Frame
6 months
Title
Body Composition Changes
Description
Body composition changes will be assessed by measuring lean body mass and fat mass by dual energy X-ray absorptiometry (DEXA).
Time Frame
6 months
Title
Muscle Strength Changes
Description
Muscle strength will be assessed by measuring maximal voluntary strength in the leg press exercise by the 1-RM method;
Time Frame
6 months
Title
Physical Function Changes
Description
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
Time Frame
6 months
Title
Objective Measures of Habitual Physical Activity Changes
Description
To determine changes in daily physical activity, validated actigraphy will be used.
Time Frame
6 months
Title
Caregiver Burden Changes
Description
The Brief Assessment Scale for Caregivers (BASC) will be used to determine caregiver burden.
Time Frame
6 months
Title
Work Productivity
Description
Loss of productivity will be evaluated using the Work Productivity and Impairment (WPAI) scale.
Time Frame
6 months
Title
Sleep Quality Changes
Description
Sleep quality will be assessed using the validated Pittsburgh Sleep Quality Index (PSQI) scale and by using actigraphy
Time Frame
6 months
Title
Qualitative Survey
Description
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).
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men with active lung or colorectal 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 hormone-dependent cancers (breast, prostate) Men with brain metastases from any type of cancer Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months Current use of systemic glucocorticoids (unless part of the chemotherapy regimen) Appetite stimulating agents (e.g. megestrol acetate) within the past 1 month Hematocrit >48%, serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal 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 >8.5% Body mass index (BMI) >40 kg/m2 Untreated unipolar depression (treated depression is allowed) Bipolar disorder or schizophrenia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Garcia, MD, Phd
Phone
206 764 2984
Email
jg77@uw.edu
Facility Information:
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Egidio Del Fabbro, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Braga, MD
Phone
617-525-9144
Email
mbraga2@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Shehzad Basaria, MD
Facility Name
Veterans Affairs Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Paulsen, BS
Phone
206-277-1163
Email
Lauren.Paulsen@va.gov
First Name & Middle Initial & Last Name & Degree
Lindsey Anderson, PhD
Phone
2062776719
Email
Lindsey.Anderson5@va.gov
First Name & Middle Initial & Last Name & Degree
Jose M Garcia, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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