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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Assess the impact of low-dose naltrexone (LDN) on Cancer-related fatigue as measured by the FACIT-F questionnaire."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a daily 3 mg naltrexone pill can reduce tiredness in men with prostate cancer. It is for men getting hormone therapy, also called ADT, with or without newer hormone medicines.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have confirmed prostate cancer that has returned based on blood tests or has spread to other parts of the body.
- Be on ADT, a treatment that lowers male hormones. You may also take newer hormone medicines.
- The listing says ADT must have been used for at least 3 months, but also says hormone treatment must start within 3 months of signing up. Ask the study team to explain this timing.
- Be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
- Have blood cell counts, liver tests, and kidney tests that meet the study’s limits. Your heart must pump out more than 45% of its blood with each beat.
- Score below 43 on the FACIT-F survey, which measures tiredness.
- Be able to understand the study and agree to sign a consent form.
Who can't join
- Had chemotherapy in the past 3 months.
- Are taking PARP inhibitors, a type of cancer medicine.
- The listing mentions taking a medicine now or within 10 days before joining, but does not name it. Ask the study team about this rule.
- Are getting any other experimental drugs.
- Have had an allergic reaction to medicines like naltrexone or other drugs used in the study.
- Have had another cancer, except nonmelanoma skin cancer, unless it has been completely gone and untreated for at least 5 years.
- Have an uncontrolled illness, such as an active infection, or a history of heart failure. Other listed concerns include unstable chest pain, an uneven heartbeat, or mental health or life problems that would prevent following study rules.
- Have acute hepatitis, a sudden liver inflammation, or liver failure.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
AR
- University of Arkansas for Medical Sciences · Little Rock, AR 72205Anuradha Kunthur, MD · Study contact · 501-686-8530Anuradha Kunthur, MD · Principal investigatorMore trials in Little Rock