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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Healthy Diet Text Messaging; Behavioral: Prolonged Nightly Fasting (PNF+)

Detailed Description

Background/Objectives: This study aimed to assess the feasibility and acceptability of a 3-month health coaching intervention to promote PNF and healthy diet for men on ADT for PCa.

Methods: The study was carried out via a two-armed randomized controlled trial including 40 patients with PCa at a medical center in Philadelphia. During the 3-month period, the intervention group (PNF+) received health coaching utilizing an interactive text message system, and the control group received healthy eating text messages for the same duration. The outcome variables were feasibility and acceptability.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Diet Group; 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.	Behavioral: Healthy Diet Text Messaging; Healthy Diet Group will receive general messages about healthy diet derived from AICR.; Other Names: health eating attention control group
Experimental: Prolonged Nightly Fasting (PNF+); 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	Behavioral: Prolonged Nightly Fasting (PNF+); participants will be invited to participate in weekly counseling calls with a trained health coach 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 sleep pattern data. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting.; Other Names: interactive TXT-integrated intervention; Time-Restricted feeding; PNF+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual Rate	Percentage of eligible participants who consent and enroll in the study.	12 months
Attrition Rate	Percentage of enrolled participants completing post-intervention follow-up.	Approximately 3 months
Time-Restricted Eating Compliance	Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE	Approximately 3 months
Number of Adverse Events	Number of Adverse Events	Approximately 3 months
Patient Satisfaction	Patient satisfaction, as measured from Client Satisfaction Quesionnaire-8 item version (CSQ-8), a validated measure that elicits the client's perspective on the value of serves received37. Qualitatively, a structured interview guide will be developed to assess the behavioral determinants (barriers and facilitators to adoption of the 16:8 TRE, including the usefulness and practicality of the PNF+ intervention and any specific feedback for improvement. Sample questions include: asking participants to: 1) identify the greatest benefit from PNF+ program; 2) indicate the greatest challenge from be compliant with the PNF+ program; 3) describe the way in which their neurological function or memory had changed (improved or worsened); and 4) indicate the driving force that bring them to participate in the PNF+ program.	Approximately 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue short form. The FACIT-F includes 13 items, such as "I feel fatigued" and "I feel weak all over." Items are scored on a range from 0 to 52 with higher scores indicating better quality of life or less fatigue. This will be measured at baseline and all follow ups to inform future trials. The pre-post change scores will be calculated for each participant and standard deviations of the change scores. Intervention effects will be tested using Wilcoxon tests or Fisher's exact tests, as appropriate.	Baseline up to 3 months
Change in Weight	Weight: participants' weight will be collected from EMR and asked about self-reported weights during health coaching check in. The pre-post change scores will be calculated for each participant and standard deviations of the change scores. Intervention effects will be tested using Wilcoxon tests or Fisher's exact tests, as appropriate.	Baseline up to 3 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Pennsylvania Department of Health
• Investigators: Principal Investigator: Kuang-Yi Wen, PhD, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Actual): May 2, 2025
• Study Completion (Actual): May 2, 2025

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Androgen Deprivation Therapy; ADT; PCa; metabolic disturbances; mobile text messaging; Nightly Fasting; telehealth coaching
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 19S.725; JT 42246 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No