A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled
Sponsor: Thomas Jefferson University
Trial Details
| Condition | Prostate Cancer |
| Intervention | Prolonged Nightly Fasting (PNF+); Healthy Diet Text Messaging |
| Phase | NA |
| Status | Completed |
| Participants | 40 |
| Est. Completion | 2 May 2025 |
| Last Updated | 8 May 2026 |
Primary Outcome
Accrual Rate; Attrition Rate; Time-Restricted Eating Compliance; Number of Adverse Events; Patient Satisfaction
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: * Must be 18 years of age or older * Provide signed and dated informed consent form * Had a histological diagnosis of PCa (Stage IIA-IVB) * Are beginning or receiving ADT (including medical castration with LHRH-agonist-antagonist androgen receptor modulators) for PCa with an anticipated duration of ≥ 3 months. The ADT is defined as: (a) Gonadotropin Releasing Hormone (GNRH) agonist (including leuprolide \[Lupron/Eligard\], goserelin \[Zoladex\], triptorelin \[Trelstar\], histrelin \[Vantas\], and abiraterone \[Zytiga\]) alone; (b) GNRH agonist with oral androgen receptor blockade (including bicalutamide \[Casodex\], flutamide \[Eulexin\], and enzalutamide \[Xtandi\]), and (c) GNRH agonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors. Patients on androgen receptor modulators and second-generation androgen receptor antagonists will qualify. * Intermittent ADT will be allowed as long as the overall duration is more than 3 months. * BMI ≥25 kg/m2 * Radiation therapy will be allowed concurrently. * Willing and able to comply with the protocol for the duration of the study * Able to speak, read and write English * Has a mobile phone with TXT capability. Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Inability to tolerate a normal diet (may include an active malabsorption syndrome at time of consent (i.e. Crohn's disease, major bowel resection leading to permanent malabsorption) * Patients on concurrent chemotherapy will be excluded. * ECOG score \> 2 * Medications such as finasteride/dutasteride/saw palmetto are not allowed. * Insulin injection or glyburide medication
Trial Sites
Countries
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