NCT07224009

Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

Phase II Clinical Trial Evaluating the Safety and Efficacy of Low Dose Naltrexone (LDN) for the Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Naltrexone	Naltrexone, a structurally similar compound to the opioid antagonist naloxone, but with longer half-life and higher bioavailability, was first synthesized in the 1960s and approved by Food and Drug Administration (FDA) in 1980s for treatment of opioid addiction. Its use was later expanded for management of alcohol addiction as well. The typical dose of naltrexone used for opioid and alcohol addiction is 50-100mg \[19\]. Naltrexone at one-tenth of the original addiction treatment dose, referred to as LDN, exhibits interesting paradoxical pharmacology and enhances endogenous opioid production. It also showed exhibiting multiple other pharmacological effects ranging from inhibition of proliferation of cancer cells, modulating immune response there by slowing the progression of autoimmune diseases and exhibiting the inhibitory effect of pro-inflammatory cytokines thereby reducing the symptoms of neuropathic and non-cancer related pain.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2025-11-03
• Last updated: 2026-03-02

Regulatory

• FDA-regulated drug study