Dietary Intervention in Patients with a History of Melanoma
Controlled Dietary Interventions in Patients with Melanoma
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (fiber-rich diet)
Patients consume a whole-foods, fiber-rich diet for 6 weeks.
|
Ancillary studies
Consume whole-foods, fiber-rich diet
Other Names:
Consume high fat, low carbohydrate (ketogenic) diet
Other Names:
|
|
Experimental: Group II (ketogenic diet)
Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.
|
Ancillary studies
Consume whole-foods, fiber-rich diet
Other Names:
Consume high fat, low carbohydrate (ketogenic) diet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of conducting a controlled feeding study in melanoma patients
Time Frame: Up to 1 year
|
Defined by >= 25% of eligible patients enrolling on the protocol.
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Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer McQuade, M.D. Anderson Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0857 (Other Identifier: UW-Madison IRB)
- NCI-2019-02496 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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