Skip to main content
OpenTrials
Completed

NCT Number: NCT07462403

A Prolonged Nightly Fasting for Men on ADT for PCa

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged Nightly Fasting (PNF+)

Behavioral

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+

Healthy Diet Text Messaging

Behavioral

Healthy Diet Group will receive general messages about healthy diet derived from AICR.

Other names: health eating attention control group

Primary outcomes

  1. Accrual Rate

    Time frame: 12 months

    Percentage of eligible participants who consent and enroll in the study.

  2. Attrition Rate

    Time frame: Approximately 3 months

    Percentage of enrolled participants completing post-intervention follow-up.

  3. Time-Restricted Eating Compliance

    Time frame: Approximately 3 months

    Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE

  4. Number of Adverse Events

    Time frame: Approximately 3 months

    Number of Adverse Events

  5. Patient Satisfaction

    Time frame: Approximately 3 months

    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.

Other outcomes

  1. Fatigue

    Time frame: Baseline up to 3 months

    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.

  2. Change in Weight

    Time frame: Baseline up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.