Status:
NOT_YET_RECRUITING
Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
Lead Sponsor:
University of Arkansas
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The study is being done to see if a small daily dose of naltrexone (LDN, 3 mg pill) can help reduce tiredness (fatigue) in men with prostate cancer. All men in this study are being treated with hormon...
Detailed Description
The purpose of this study is to learn if low dose naltrexone can safely improve energy and reduce fatigue in men receiving these treatments. Primary Objectives 1. Characterize mitochondrial bioenerg...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically or cytologically confirmed biochemical recurrence and on ADT for at least 3 months. Metastatic castrate-sensitive and castrate-resistant prostate cancer on ADT with or without novel hormonal therapy like apalutamide, darolutamide, enzalutamide and abiraterone.
- Initiation of hormonal ablative therapy within 3 months of registration.
- ECOG performance status \<3.
- Patients must have normal organ and marrow function as defined below:
- leukocytes \>3,000/μL
- absolute neutrophil count \>1,500/μL
- platelets \>100,000/μL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
- creatinine ≤2.5.0
- left ventricular ejection fraction \>45%
- FACIT-F score \< 43 on screening
- Ability to understand and the willingness to sign a written informed consent document.
- Exclusion Criteria
- Prior chemotherapy received in the last three months.
- Patients currently on PARP inhibitors.
- Currently taking or have taken within 10 days of enrollment.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Naltrexone or other agents used in the study.
- History of other malignancies other than nonmelanoma skin cancer, unless in complete remission and off therapy for that disease for at least 5 years.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any Patient with acute hepatitis and liver failure are excluded.
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07224009
Start Date
January 1 2026
End Date
January 1 2029
Last Update
November 4 2025
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