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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Arkansas

About this trial

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.

Eligibility criteria

Qualifiers

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.

leukocytes >3,000/μL

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Naltrexone

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators