Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
- Registration Number
- NCT07224009
- Lead Sponsor
- University of Arkansas
- 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 hormone therapy (also called androgen deprivation therapy, or ADT). Some may also be taking newer hormone medicines such as apalutamide, daralutamide, enzalutamide, or abiraterone.
- 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 bioenergetics, inflammation and oxidative stress after ADT and the remediating effects of LDN.
2. Assess the impact of low-dose naltrexone (LDN) on Cancer-related fatigue as measured by the FACIT-F questionnaire.
Secondary Objectives
1. Evaluate quality of life (QOL) measures \[Functional Assessment of Cancer Therapy-Prostate (FACT-P) on subjects receiving LDN.
2. Evaluate safety and tolerability of LDN.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-arm study of low-dose naltrexone (LDN) Naltrexone Low dose Naltrexone 3 mg is taken orally once daily to be taken with food at night. Patient will be given a pill dairy to assure compliance with the medication.
- Primary Outcome Measures
Name Time Method Characterize oxidative stress after ADT and the remediating effects of LDN 30 months Characterize mitochondrial bioenergetics after ADT and the remediating effects of LDN 30 months Characterize inflammation after ADT and the remediating effects of LDN 30 months Assess the impact of low-dose naltrexone (LDN) on Cancer-related fatigue as measured by the FACIT-F questionnaire 30 months
- Secondary Outcome Measures
Name Time Method Evaluate quality of life (QOL) measures [Functional Assessment of Cancer Therapy-Prostate (FACT-P) on subjects receiving LDN 30 months Evaluate safety and tolerability of LDN by assessing the number of participants with treatment-related adverse events graded by CTCAE v5.0 30 months