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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Response to cancer treatment [Срок оценки: 6 Month visit]

Вторичные конечные точки (8)

• Castration resistance 1 [Срок оценки: 6 Month visit]
• Castration resistance 2 [Срок оценки: 6 Month visit]
• Metabolic Toxicity 1 [Срок оценки: Change from Baseline to 6 Month visit]
• Metabolic Toxicity 2 [Срок оценки: Change from Baseline to 6 Month visit]
• Metabolic Toxicity 3 [Срок оценки: Change from Baseline to 6 Month visit]
• Metabolic Toxicity 4 [Срок оценки: Change from Baseline to 6 Month visit]
• Self-reported overall well-being [Срок оценки: Change from Baseline to 6 Month visit]
• Self-reported energy levels [Срок оценки: Change from Baseline to 6 Month visit]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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