Dietary Intervention in Patients With a History of Melanoma

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ClinicalTrials.gov Identifier: NCT03950635

Recruitment Status : Recruiting

First Posted : May 15, 2019

Last Update Posted : November 18, 2023

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Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

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.

Condition or disease	Intervention/treatment	Phase
Melanoma	Dietary Supplement: Dietary Intervention Other: Questionnaire Administration	Phase 1

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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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Controlled Dietary Interventions in Patients With Melanoma
Actual Study Start Date :	April 16, 2019
Estimated Primary Completion Date :	November 29, 2023
Estimated Study Completion Date :	November 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

MedlinePlus related topics: Melanoma

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950635

Contacts

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Contact: Jennifer McQuade	713-792-2921	jmcquade@mdanderson.org

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	Jennifer McQuade	M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0857.html This link exits the ClinicalTrials.gov site

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Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT03950635
Other Study ID Numbers:	2018-0857 NCI-2019-02496 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0857 ( Other Identifier: M D Anderson Cancer Center )
First Posted:	May 15, 2019 Key Record Dates
Last Update Posted:	November 18, 2023
Last Verified:	November 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas

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