Clinical trial · Interventional
A Prolonged Nightly Fasting for Men on ADT for PCa
A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled
NCT07462403CI-TRIAL-00110865completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This small study tested a 3-month text-based health coaching program for men with prostate cancer on hormone therapy. The program was feasible and well accepted, with participants showing good engagement and some improvements in weight and quality of life. However, differences between groups were not statistically significant, so larger studies are needed to confirm the benefits.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healthy Diet Text Messaging | Behavioral | — | UNRESOLVED |
| Prolonged Nightly Fasting (PNF+) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prolonged Nightly Fasting (PNF+)
- description
- Participants will be invited to participate in weekly calls with a trained health coach during the and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleeping behaviors. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting. The health eating attention control group: participants will
- interventionNames
- Behavioral: Prolonged Nightly Fasting (PNF+)
- type
- ACTIVE_COMPARATOR
- label
- Healthy Diet Group
- description
- The health eating attention control group: participants will receive text messages twice a day to focus on information and tips on general healthy eating, based on AICR evidence-based materials.
- interventionNames
- Behavioral: Healthy Diet Text Messaging
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.