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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month visit
Awards & highlights
Study Summary
This trial tests a fasting-mimicking diet to see if it can improve cancer treatment outcomes for prostate cancer.
Who is the study for?
This trial is for men with metastatic castrate sensitive prostate adenocarcinoma who are starting first-line treatment. They must understand English or Spanish, have phone access, and be able to follow the study's requirements. Men with a BMI under 20, significant weight loss recently, on weight loss plans or unstable diabetes medications, practicing fasting diets that affect the study, or with serious health issues like heart disease aren't eligible.Check my eligibility
What is being tested?
The study compares the effects of a Fasting Mimicking Diet (FMD) versus a standard diet in patients undergoing cancer treatment. Participants will eat special L-Nutra products for 5 days each month over half a year while continuing their usual cancer care.See study design
What are the potential side effects?
Potential side effects from the Fasting Mimicking Diet may include fatigue, hunger pangs, headaches and dizziness due to calorie restriction. However specific side effects related to this diet during the trial haven't been detailed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response to cancer treatment
Secondary outcome measures
Castration resistance 1
Castration resistance 2
Metabolic Toxicity 1
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fasting Mimicking DietExperimental Treatment1 Intervention
Intermittent fasting using a fasting mimicking diet
Group II: Standard Anti-Cancer DietPlacebo Group1 Intervention
Standard Anti-Cancer Diet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fasting Mimicking Diet (FMD)
2020
N/A
~110
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Who is running the clinical trial?
Stephen FreedlandLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,933,406 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lost 10% or more of my weight in the past 6 months.My prostate cancer has spread and responds to hormone therapy.I can read and write in English or Spanish and have a phone for dietitian calls.I am a man starting or planning to start first-line ADT for prostate cancer soon.I am a man with diabetes not on stable diabetes medication for 6 months or without doctor's approval to pause it for 5 days.My BMI is less than 20.I am a man currently trying to lose weight or planning weight loss surgery soon.
Research Study Groups:
This trial has the following groups:- Group 1: Fasting Mimicking Diet
- Group 2: Standard Anti-Cancer Diet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Fasting Mimicking Diet offer any potential health risks?
"The Fasting Mimicking Diet received a score of 2 as this is an experimental clinical trial, meaning that while there may be some evidence confirming safety, no data exists regarding efficacy."
Answered by AI
Is this trial still accepting new participants?
"Sadly, the clinicaltrials.gov database suggests that no new patients are being accepted for this trial at present. It was initially posted on June 30th 2023 and underwent its most recent edits on April 14th 2023. There is still hope though - 815 other studies currently have open recruitment slots!"
Answered by AI
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