A Prolonged Nightly Fasting for Men on ADT for PCa

NCT07462403 | Completed

• 2 other identifiers: 19S.725JT 42246
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Androgen Deprivation Therapy; ADT; metabolic disturbances; mobile text messaging; PCa; Nightly Fasting; telehealth coaching

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Fatigue

  Baseline up to 3 months

• Change in Weight

  Baseline up to 3 months

Study Arms (2)

Prolonged Nightly Fasting (PNF+)

EXPERIMENTAL

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+)

Healthy Diet Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: interactive TXT-integrated intervention, Time-Restricted feeding, PNF+

Prolonged Nightly Fasting (PNF+)

Healthy Diet Text Messaging BEHAVIORAL

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

Also known as: health eating attention control group

Healthy Diet Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kuang-Yi Wen, PhD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized with an allocation ratio of 2:1 to either the PNF+ intervention group or Healthy Diet Group.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: May 2, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)