NCT04049331

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
9mo left

Started Mar 2021

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2021Jan 2027

First Submitted

Initial submission to the registry

July 23, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

5.9 years

First QC Date

July 23, 2019

Last Update Submit

March 6, 2025

Conditions

Hypogonadism, MaleFatigue Syndrome, Chronic

Keywords

testosteronehypogonadismcancer related fatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue change

    (Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) questionnaire

    9 months

Secondary Outcomes (9)

  • Sexual function change

    9 months

  • Sexual function change

    9 months

  • Body composition change

    9 months

  • Changes to mood and well-being

    9 months

  • Muscle strength change

    9 months

  • +4 more secondary outcomes

Study Arms (2)

Testosterone

EXPERIMENTAL

Testosterone undecanoate injection 750 MG/3 ML

Drug: Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]

Placebo

PLACEBO COMPARATOR

clinical grade saline 0.9% sodium chloride injection

Other: placebo

Interventions

Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]DRUG

first two doses four weeks apart; following three more doses every ten weeks.

Also known as: study drug
Testosterone
placeboOTHER

first two doses four weeks apart; following three more doses every ten weeks.

Placebo

Eligibility Criteria

Age18 Years - 54 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

EunuchismFatigue Syndrome, ChronicHypogonadism

Interventions

testosterone undecanoateDrug Evaluation

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesMuscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Jose M Garcia, MD, PhD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose M Garcia, MD, PhD

CONTACT

206 764 2984jg77@uw.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2019

First Posted

August 8, 2019

Study Start

March 22, 2021

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)