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Dietary Intervention in Patients With a History of Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950635
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : July 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date July 17, 2020
Actual Study Start Date  ICMJE April 16, 2019
Estimated Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
Feasibility of conducting a controlled feeding study in melanoma patients measured by enrollment. [ Time Frame: Up to 1 year ]
Defined by >= 25% of eligible patients enrolling on the protocol.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Intervention in Patients With a History of Melanoma
Official Title  ICMJE Controlled Dietary Interventions in Patients With Melanoma
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Melanoma
Intervention  ICMJE
  • 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
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Group I (fiber-rich diet)
    Patients consume a whole-foods, fiber-rich diet for 6 weeks.
    Interventions:
    • Dietary Supplement: Dietary Intervention
    • Other: Questionnaire Administration
  • Experimental: Group II (ketogenic diet)
    Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.
    Interventions:
    • Dietary Supplement: Dietary Intervention
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 29, 2021
Estimated Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer McQuade 713-792-2921 jmcquade@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03950635
Other Study ID Numbers  ICMJE 2018-0857
NCI-2019-02496 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0857 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jennifer McQuade M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP