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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832086
• Other study ID #: IIT2023-02-FREEDLAND-FAST-PRO
• Secondary ID: 1R01CA280081-01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 13, 2023
• Est. completion date: March 30, 2029

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Recruitment Navigator
• Phone: 3104232133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: March 30, 2029
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Beckman Research Institute of the City of Hope	Duarte	California
United States	Duke University	Durham	North Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Freedland	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to cancer treatment	Will be measured by the proportion of patients who achieved PSA nadir =0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir.	6 Month visit
Secondary	Castration resistance 1	will be measured by Testosterone (ng/dl)	6 Month visit
Secondary	Castration resistance 2	will be measured by PSA levels (ng/mL)	6 Month visit
Secondary	Metabolic Toxicity 1	Will be measured by the changes in HbA1c	Change from Baseline to 6 Month visit
Secondary	Metabolic Toxicity 2	Will be measured by the changes in waist circumference	Change from Baseline to 6 Month visit
Secondary	Metabolic Toxicity 3	Will be measured by the changes in fat mass (assessed via bioelectrical expedience)	Change from Baseline to 6 Month visit
Secondary	Metabolic Toxicity 4	Will be measured by the changes in body weight	Change from Baseline to 6 Month visit
Secondary	Self-reported overall well-being	will be measured in changes in the scores calculated from the Medical Outcomes Study Short Form Health Survey (SF-12) questionnaire. Scores can range from 12-56 with a higher score indicating a better outcome.	Change from Baseline to 6 Month visit
Secondary	Self-reported energy levels	will be measured in changes in the scores calculated from the Godin leisure-time physical activity questionnaire. Scores can range from 0 and above, with a higher score indicating a better physical activity outcome.	Change from Baseline to 6 Month visit