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.

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.

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