Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT03950635
Status:
TERMINATED
Last Update Posted:
2024-12-04
First Post:
2019-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Intervention in Patients with a History of Melanoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Controlled Dietary Interventions in Patients with Melanoma
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively Complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research trial studies the effects of diet in patients with a history of melanoma. We are studying the impact of 2 different diets; a whole-foods, fiber-rich diet and a ketogenic diet. Participants will be assigned to one of these diets. During this study, participants will be provided all food at no cost for the entire 6-week study. Food can be picked up or shipped to the participant's home. However, participants will need to come into MD Anderson Cancer Center in Houston, TX, for the initial screening visit and for blood tests every 2 weeks during the study.
Detailed Description:
Study Background:
Whole-foods, fiber-rich diet rationale: Recent studies have shown that the gut microbiome (the trillions of bacteria that live in our intestines) can influence our immune system function. Diet plays a key role in shaping the gut microbiome. We will examine the effects of a whole-food, fiber-rich diet on the gut microbiome within patients with a history of melanoma.
Ketogenic diet rationale: The ketogenic diet is a very-low-carbohydrate, high-fat diet. The goal of this diet is to change the body's fuel source from carbohydrates to fat and to lower levels of insulin. We will examine the effects of a ketogenic diet to change metabolism within patients with a history of melanoma.
Who can participate?
To be eligible for the study, participants must meet the following criteria:
* Be at least 18 years old;
* Meet the study requirements for Body Mass Index (BMI);
* Have had melanoma within the last 5 years;
* Be cancer-free at the start of the trial;
* Have not received systemic therapy within the last year; and
* Have no medical issues that would make them unable to follow these eating plans.
Study Design:
Our study will enroll up to 10 participants to each diet (high-fiber or ketogenic). After screening, participants will have baseline assessment performed that will include collecting diet information, blood and fecal samples, and body composition information. Participants will then eat the provided diets for the next 6 weeks while coming in every 2 weeks for blood and stool specimen collection. Six (6)weeks after the diet intervention is complete, participants will come back to MD Anderson for one last end of study visit.
Who makes the meals?:
All calorie-containing food and beverages will be provided by either the MD Anderson Cancer Center Bionutrition Research Core or Savor Health (a third-party vendor contracted by MD Anderson).
Costs: There will be no cost to participate in this study.
Benefits:
All food and beverages you will eat as part of this study will be provided by the study and can be shipped directly to your home. The results will be used to help us design future dietary intervention trials in Melanoma patients receiving immunotherapy. Please note, participants can withdraw from the study at any time without consequences.
Study PI: Dr. Jennifer McQuade
NCT#: NCT03950635
Contact Info:
Melanoma Medical Oncology (713)-792-5500 MelanomaDiet@mdanderson.org
Where: MD Anderson Cancer Center, Department of Melanoma Medical Oncology, Houston, TX
Whole-foods, fiber-rich diet rationale: Recent studies have shown that the gut microbiome (the trillions of bacteria that live in our intestines) can influence our immune system function. Diet plays a key role in shaping the gut microbiome. We will examine the effects of a whole-food, fiber-rich diet on the gut microbiome within patients with a history of melanoma.
Ketogenic diet rationale: The ketogenic diet is a very-low-carbohydrate, high-fat diet. The goal of this diet is to change the body's fuel source from carbohydrates to fat and to lower levels of insulin. We will examine the effects of a ketogenic diet to change metabolism within patients with a history of melanoma.
Who can participate?
To be eligible for the study, participants must meet the following criteria:
* Be at least 18 years old;
* Meet the study requirements for Body Mass Index (BMI);
* Have had melanoma within the last 5 years;
* Be cancer-free at the start of the trial;
* Have not received systemic therapy within the last year; and
* Have no medical issues that would make them unable to follow these eating plans.
Study Design:
Our study will enroll up to 10 participants to each diet (high-fiber or ketogenic). After screening, participants will have baseline assessment performed that will include collecting diet information, blood and fecal samples, and body composition information. Participants will then eat the provided diets for the next 6 weeks while coming in every 2 weeks for blood and stool specimen collection. Six (6)weeks after the diet intervention is complete, participants will come back to MD Anderson for one last end of study visit.
Who makes the meals?:
All calorie-containing food and beverages will be provided by either the MD Anderson Cancer Center Bionutrition Research Core or Savor Health (a third-party vendor contracted by MD Anderson).
Costs: There will be no cost to participate in this study.
Benefits:
All food and beverages you will eat as part of this study will be provided by the study and can be shipped directly to your home. The results will be used to help us design future dietary intervention trials in Melanoma patients receiving immunotherapy. Please note, participants can withdraw from the study at any time without consequences.
Study PI: Dr. Jennifer McQuade
NCT#: NCT03950635
Contact Info:
Melanoma Medical Oncology (713)-792-5500 MelanomaDiet@mdanderson.org
Where: MD Anderson Cancer Center, Department of Melanoma Medical Oncology, Houston, TX
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: