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Trial Title:
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
NCT ID:
NCT05832086
Condition:
Prostate Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
Fasting
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Fasting Mimicking Diet (FMD)
Description:
Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6
cycles total in 6 months.
Arm group label:
Fasting Mimicking Diet
Intervention type:
Behavioral
Intervention name:
Standard Anti-Cancer Diet
Description:
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.
Arm group label:
Standard Anti-Cancer Diet
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.
Criteria for 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
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beckman Research Institute of the City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tanya Dorff, MD
Phone:
(626) 256-4673
Email:
tdorff@coh.or
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephen Freedland, MD
Phone:
310-423-3497
Email:
Stephen.Freedland@cshs.org
Contact backup:
Last name:
Gillian Gresham, PhD
Contact backup:
Last name:
Edwin Posadas, MD
Contact backup:
Last name:
Mourad Tighiouart, PhD
Contact backup:
Last name:
Sungyong You, PhD
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pao-Hwa Lin, PhD
Phone:
(919) 660-6685
Email:
lin00004@mc.duke.edu
Contact backup:
Last name:
Daniel George, MD
Contact backup:
Last name:
Matthew Labriola, MD
Start date:
September 13, 2023
Completion date:
March 30, 2029
Lead sponsor:
Agency:
Stephen Freedland
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832086
