Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

Last updated: November 2, 2024
Sponsor: Stephen Freedland
Overall Status: Active - Recruiting

Phase

2

Condition

Adenocarcinoma

Prostate Cancer

Treatment

Standard Anti-Cancer Diet

Usual Diet

Fasting Mimicking Diet (FMD)

Clinical Study ID

NCT05832086
IIT2023-02-FREEDLAND-FAST-PRO
1R01CA280081-01
  • Male

Study Summary

This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.

This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostatehistologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRIscan)

  • Men receiving or planning to start first-line intensified ADT (within 30 days ofregistration) with abiraterone, apalutamide, enzalutamide, or darolutamide with orwithout current or prior chemotherapy

  • Reads, writes, and understands English or Spanish and has telephone access forremote contact with the study dietitian.

  • Written informed consent obtained from subject and ability for subject to complywith the requirements of the study.

Exclusion

Exclusion Criteria:

  • Allergies to any ingredients listed on the Xentigen Ingredient List

  • Men with diabetes who are not on stable doses of antihyperglycemic medication for atleast 6 months and without physician consent that they may safely holdantihyperglycemic medication during the 5 days of FMD

  • Regularly practicing a fasting diet that in the opinion of the study physician wouldimpact study participation

  • Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoingalcohol/drug abuse) that in the opinion of the study physician would precludeenrollment in this study.

  • Body Mass Index (BMI) <20kg/m2

  • Men actively trying to lose weight OR on weight loss medications (including but notlimited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery inthe next six months

  • Self-reported weight loss ≥ 10% in the last 6 months

Study Design

Total Participants: 138
Treatment Group(s): 3
Primary Treatment: Standard Anti-Cancer Diet
Phase: 2
Study Start date:
September 13, 2023
Estimated Completion Date:
March 30, 2029

Connect with a study center

  • Beckman Research Institute of the City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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