Clinical trial NCT03950635: Dietary Intervention in Patients with a History of Melanoma
Official title: Controlled Dietary Interventions in Patients with Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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).

Primary outcomes:
measure: Feasibility of conducting a controlled feeding study in melanoma patients
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jennifer McQuade
role: PRINCIPAL_INVESTIGATOR
References: