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)
Sponsor: University of Arkansas
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Characterize mitochondrial bioenergetics after ADT and the remediating effects of LDN
Time frame: 30 months
Characterize inflammation after ADT and the remediating effects of LDN
Time frame: 30 months
Characterize oxidative stress after ADT and the remediating effects of LDN
Time frame: 30 months
Assess the impact of low-dose naltrexone (LDN) on Cancer-related fatigue as measured by the FACIT-F questionnaire
Time frame: 30 months
Secondary Endpoints
Evaluate quality of life (QOL) measures [Functional Assessment of Cancer Therapy-Prostate (FACT-P) on subjects receiving LDN
Evaluate safety and tolerability of LDN by assessing the number of participants with treatment-related adverse events graded by CTCAE v5.0
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 inhibit…
Read full criteria on CT.gov →✦ Analyst Commentary
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