Dietary Intervention in Patients With a History of Melanoma
Primary Purpose
Melanoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Dietary Intervention
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- Melanoma resected within the last 5 years, currently no evidence of disease (NED) and not on systemic therapy.
- Body mass index (BMI) 18.5-40 kg/m^2.
- English-speaking.
- Self-reported willingness to exclusively eat the provided diets.
- Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
- Creatinine (Cr) < 1.5 mg/dL.
- Liver function tests (LFTs) 2 x upper limit of normal (ULN).
- Fasting glucose < 125 mg/dL.
- Women of child-bearing (WOCP) potential must have negative urine pregnancy test (UPT) within 1 week prior to dual x-ray absorptiometry (DEXA) scan.
Exclusion Criteria:
- Systemic treatment for melanoma within the past 1 year.
- Medical contraindications to the intervention diet as determined by the treating physician.
- Self-reported major dietary restrictions related to the intervention.
- Diagnosis of diabetes mellitus type I or type II that requires medical treatment.
- Unable or unwilling to undergo study procedures.
- Antibiotic use within the last 30 days (self-reported and/or noted by the treating physician).
- Regularly taking probiotics, fiber supplements, or bile acid sequestrants, exogenous ketones, weight loss supplements, appetite suppressants, carnitine supplements, creatine supplements or diuretics within the last 30 days (self-reported and/or noted by the treating physician).
- Currently following a ketogenic diet with > 70% calories derived from fat or consuming > 40 grams of fiber per day or a vegetarian or vegan diet.
- Current self-reported smoker or heavy drinker (defined as > 14 drinks per week) or current self-reported illicit drug use.
- Pregnant or lactating.
- Low density lipoprotein (LDL) > 200 mg/dL (within 28 days of screening).
- Triglycerides > 350 mg/dL (within 28 days of screening).
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I (fiber-rich diet)
Group II (ketogenic diet)
Arm Description
Patients consume a whole-foods, fiber-rich diet for 6 weeks.
Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.
Outcomes
Primary Outcome Measures
Feasibility of conducting a controlled feeding study in melanoma patients
Defined by >= 25% of eligible patients enrolling on the protocol.
Secondary Outcome Measures
Full Information
NCT ID
NCT03950635
First Posted
May 6, 2019
Last Updated
June 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03950635
Brief Title
Dietary Intervention in Patients With a History of Melanoma
Official Title
Controlled Dietary Interventions in Patients With Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
November 29, 2023 (Anticipated)
Study Completion Date
November 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
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
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I (fiber-rich diet)
Arm Type
Experimental
Arm Description
Patients consume a whole-foods, fiber-rich diet for 6 weeks.
Arm Title
Group II (ketogenic diet)
Arm Type
Experimental
Arm Description
Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Consume whole-foods, fiber-rich diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Consume high fat, low carbohydrate (ketogenic) diet
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of conducting a controlled feeding study in melanoma patients
Description
Defined by >= 25% of eligible patients enrolling on the protocol.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Melanoma resected within the last 5 years, currently no evidence of disease (NED) and not on systemic therapy.
Body mass index (BMI) 18.5-40 kg/m^2.
English-speaking.
Self-reported willingness to exclusively eat the provided diets.
Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
Creatinine (Cr) < 1.5 mg/dL.
Liver function tests (LFTs) 2 x upper limit of normal (ULN).
Fasting glucose < 125 mg/dL.
Women of child-bearing (WOCP) potential must have negative urine pregnancy test (UPT) within 1 week prior to dual x-ray absorptiometry (DEXA) scan.
Exclusion Criteria:
Systemic treatment for melanoma within the past 1 year.
Medical contraindications to the intervention diet as determined by the treating physician.
Self-reported major dietary restrictions related to the intervention.
Diagnosis of diabetes mellitus type I or type II that requires medical treatment.
Unable or unwilling to undergo study procedures.
Antibiotic use within the last 30 days (self-reported and/or noted by the treating physician).
Regularly taking probiotics, fiber supplements, or bile acid sequestrants, exogenous ketones, weight loss supplements, appetite suppressants, carnitine supplements, creatine supplements or diuretics within the last 30 days (self-reported and/or noted by the treating physician).
Currently following a ketogenic diet with > 70% calories derived from fat or consuming > 40 grams of fiber per day or a vegetarian or vegan diet.
Current self-reported smoker or heavy drinker (defined as > 14 drinks per week) or current self-reported illicit drug use.
Pregnant or lactating.
Low density lipoprotein (LDL) > 200 mg/dL (within 28 days of screening).
Triglycerides > 350 mg/dL (within 28 days of screening).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer McQuade
Phone
713-792-2921
Email
jmcquade@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer McQuade
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McQuade
Phone
713-792-2921
First Name & Middle Initial & Last Name & Degree
Jennifer McQuade
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
URL
http://www.mdanderson.org
Description
https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0857.html
Learn more about this trial
Dietary Intervention in Patients With a History of Melanoma
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