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Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
Trial Status: active
This phase II trial tests how well intermittent fasting using a fasting-mimicking diet works in improving response to cancer treatment in patients with castration sensitive prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The fasting mimicking diet is a 5-day program of plant-based products that are consumed and puts the body into a fasting state. Examples of these food products include: soups, broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. A fasting diet can positively change the way the body responds to cancer treatment. Many cancer treatments can negatively impact the body's heart and metabolic health, including loss of lean muscle mass, gain of fat mass, insulin resistance and altered fat metabolism. In contrast, fasting diets have shown health benefits including improved insulin sensitivity, and heart health. Consuming a fasting-mimicking diet may increase energy levels and improve quality of life, mood, sleep, and long-term survival in patients with metastatic castration sensitive prostate cancer.
Inclusion Criteria
Metastatic castrate sensitive prostate adenocarcinoma
* Adenocarcinoma prostate histologically confirmed by biopsy AND
* Metastatic disease confirmed biopsy, or magnetic resonance imaging (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
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 consecutive days of fasting-mimicking diet (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/m^2
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
Additional locations may be listed on ClinicalTrials.gov for NCT05832086.
I. To determine whether intermittent fasting using a fasting-mimicking diet in men with metastatic castration sensitive prostate cancer (mCSPC), receiving first-line intensified androgen deprivation therapy (ADT) can improve response to cancer treatment.
SECONDARY OBJECTIVES:
I. To determine whether intermittent fasting using a fasting-mimicking diet in men with mCSPC, receiving first-line intensified ADT can delay castration resistance.
II. To determine whether intermittent fasting using a fasting-mimicking diet in men with mCSPC, receiving first-line intensified ADT can reduce metabolic toxicity.
III. To determine if a fasting-mimicking diet has a positive or negative impact on self-reported energy level and overall well-being.
EXPLORATORY OBJECTIVE:
I. To determine whether tumor molecular subtype or changes in insulin, leptin, IGF1 and IGFBPs are associated with tumor control.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients consume standard of care diet and receive exercise recommendations with a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week from study dietitian on study. Patients also wear FitBit continuously on study. Patients undergo collection of blood samples at baseline and 3 and 6 months.
ARM II: Patients consume fasting-mimicking plant-based diet for 5 consecutive days every month for 6 cycles total in 6 months and receive exercise recommendations from study dietitian with a goal of 150 minutes per week of cardiovascular exercise and weight resistance training at least twice a week. Patients also wear FitBit continuously on study. Patients undergo collection of blood samples at baseline and 3 and 6 months.
