Dietary Intervention in Patients With a History of Melanoma

Controlled Dietary Interventions in Patients With Melanoma

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Other: Questionnaire Administration; Dietary supplement: Dietary Intervention; Dietary supplement: Dietary Intervention

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: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer McQuade; Phone Number: 713-792-2921; Email: jmcquade@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Jennifer McQuade; Phone Number: 713-792-2921
      • Principal Investigator: Jennifer McQuade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

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.	Other: Questionnaire Administration; Ancillary studies; Dietary supplement: Dietary Intervention; Consume whole-foods, fiber-rich diet; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Dietary supplement: Dietary Intervention; Consume high fat, low carbohydrate (ketogenic) diet; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions
Experimental: Group II (ketogenic diet); Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.	Other: Questionnaire Administration; Ancillary studies; Dietary supplement: Dietary Intervention; Consume whole-foods, fiber-rich diet; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Dietary supplement: Dietary Intervention; Consume high fat, low carbohydrate (ketogenic) diet; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of conducting a controlled feeding study in melanoma patients	Defined by >= 25% of eligible patients enrolling on the protocol.	Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jennifer McQuade, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website
• https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0857.html

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Estimated): November 29, 2023
• Study Completion (Estimated): November 29, 2023

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 2018-0857 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02496 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No