Melanoma Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | November 29, 2024 |
Est. primary completion date | November 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of conducting a controlled feeding study in melanoma patients | Defined by >= 25% of eligible patients enrolling on the protocol. | Up to 1 year |
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