Controlled Dietary Interventions in Patients with Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Feasibility of conducting a controlled feeding study in melanoma patients
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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^
- •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.
排除标准
- •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).
结局指标
主要结局
Feasibility of conducting a controlled feeding study in melanoma patients
时间窗: Up to 1 year
Defined by \>= 25% of eligible patients enrolling on the protocol.
次要结局
未报告次要终点