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Recruiting NCT05832086

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

Phase II Interventional Prostate Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fasting Mimicking Diet (FMD), Standard Anti-Cancer Diet.
Who it may be relevant to
Registry conditions: Prostate Adenocarcinoma. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Fasting Mimicking Diet (FMD)
    Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.
  • Behavioral Standard Anti-Cancer Diet
    Will receive standard of care diet and exercise recommendations from the study dietitian. The diet advice will be consistent with the American Cancer Society for cancer survivors and exercise recommendation of a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week.

Primary outcome measures

  • Response to cancer treatment [Time frame: 6 Month visit]
Secondary outcome measures (8)
  • Castration resistance 1 [Time frame: 6 Month visit]
  • Castration resistance 2 [Time frame: 6 Month visit]
  • Metabolic Toxicity 1 [Time frame: Change from Baseline to 6 Month visit]
  • Metabolic Toxicity 2 [Time frame: Change from Baseline to 6 Month visit]
  • Metabolic Toxicity 3 [Time frame: Change from Baseline to 6 Month visit]
  • Metabolic Toxicity 4 [Time frame: Change from Baseline to 6 Month visit]
  • Self-reported overall well-being [Time frame: Change from Baseline to 6 Month visit]
  • Self-reported energy levels [Time frame: Change from Baseline to 6 Month visit]

Eligibility criteria

Inclusion criteria

  • Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
  • Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
  • Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

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 at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD
  • Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation
  • Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study.
  • Body Mass Index (BMI) <20kg/m2
  • Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months
  • Self-reported weight loss ≥ 10% in the last 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Beckman Research Institute of the City of Hope — Duarte
  • Cedars-Sinai Medical Center — Los Angeles
  • Duke University — Durham

Identifiers

NCT: NCT05832086 · IIT2023-02-FREEDLAND-FAST-PRO · 1R01CA280081-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗