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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 2028 → Jan 2029
See other at-risk trials from University of Arkansas

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2026 to Aug 25, 2026
    v7
  2. Primary completion pushed from Jan 2028 to Jan 2029
    • Study completion pushed from Jan 2029 to Jan 2030
    • Start date: Jul 2026 to Aug 2026
    v6
  3. Start date: May 2026 to Jul 2026v5
  4. Start date: Mar 2026 to May 2026v4
  5. Start date: Jan 2026 to Mar 2026v3
  6. Eligibility criteria revised
    • Study description shortened, about 2 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07224009
Lead Sponsor University of Arkansas
Conditions
(from sponsor)		 Metastatic Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov