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

Primary Purpose

Prostate Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fasting Mimicking Diet (FMD)
Standard Anti-Cancer Diet
Sponsored by
Stephen Freedland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Fasting

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beckman Research Institute of the City of Hope
  • Cedars-Sinai Medical CenterRecruiting
  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fasting Mimicking Diet

Standard Anti-Cancer Diet

Arm Description

Intermittent fasting using a fasting mimicking diet

Standard Anti-Cancer Diet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Castration resistance 1
will be measured by Testosterone (ng/dl)
Castration resistance 2
will be measured by PSA levels (ng/mL)
Metabolic Toxicity 1
Will be measured by the changes in HbA1c
Metabolic Toxicity 2
Will be measured by the changes in waist circumference
Metabolic Toxicity 3
Will be measured by the changes in fat mass (assessed via bioelectrical expedience)
Metabolic Toxicity 4
Will be measured by the changes in body weight
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.
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.

Full Information

First Posted
April 3, 2023
Last Updated
October 5, 2023
Sponsor
Stephen Freedland
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05832086
Brief Title
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
Official Title
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
September 30, 2028 (Anticipated)
Study Completion Date
March 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen Freedland
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Fasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasting Mimicking Diet
Arm Type
Experimental
Arm Description
Intermittent fasting using a fasting mimicking diet
Arm Title
Standard Anti-Cancer Diet
Arm Type
Placebo Comparator
Arm Description
Standard Anti-Cancer Diet
Intervention Type
Behavioral
Intervention Name(s)
Fasting Mimicking Diet (FMD)
Intervention Description
Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Standard Anti-Cancer Diet
Intervention 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.
Primary Outcome Measure Information:
Title
Response to cancer treatment
Description
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.
Time Frame
6 Month visit
Secondary Outcome Measure Information:
Title
Castration resistance 1
Description
will be measured by Testosterone (ng/dl)
Time Frame
6 Month visit
Title
Castration resistance 2
Description
will be measured by PSA levels (ng/mL)
Time Frame
6 Month visit
Title
Metabolic Toxicity 1
Description
Will be measured by the changes in HbA1c
Time Frame
Change from Baseline to 6 Month visit
Title
Metabolic Toxicity 2
Description
Will be measured by the changes in waist circumference
Time Frame
Change from Baseline to 6 Month visit
Title
Metabolic Toxicity 3
Description
Will be measured by the changes in fat mass (assessed via bioelectrical expedience)
Time Frame
Change from Baseline to 6 Month visit
Title
Metabolic Toxicity 4
Description
Will be measured by the changes in body weight
Time Frame
Change from Baseline to 6 Month visit
Title
Self-reported overall well-being
Description
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.
Time Frame
Change from Baseline to 6 Month visit
Title
Self-reported energy levels
Description
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.
Time Frame
Change from Baseline to 6 Month visit

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Recruitment Navigator
Phone
3104232133
Email
cancer.trial.info@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Freedland, MD
Phone
310-423-3497
Email
Stephen.Freedland@cshs.org
Facility Information:
Facility Name
Beckman Research Institute of the City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Dorff, MD
Phone
626-256-4673
Email
tdorff@coh.or
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Freedland, MD
Phone
310-423-3497
Email
Stephen.Freedland@cshs.org
First Name & Middle Initial & Last Name & Degree
Gillian Gresham, PhD
First Name & Middle Initial & Last Name & Degree
Edwin Posadas, MD
First Name & Middle Initial & Last Name & Degree
Mourad Tighiouart, PhD
First Name & Middle Initial & Last Name & Degree
Sungyong You, PhD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pao-Hwa Lin, PhD
Phone
919-660-6685
Email
lin00004@mc.duke.edu
First Name & Middle Initial & Last Name & Degree
Daniel George, MD
First Name & Middle Initial & Last Name & Degree
Matthew Labriola, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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