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Behavioural Intervention
Dietary Intervention for Melanoma
Phase 1
Recruiting
Led By Jennifer McQuade
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying the effects of two different diets on patients with a history of melanoma. One diet is rich in whole foods and fiber, while the other is a ketogenic diet. Participants will be provided all food for the six-week study, but will need to come in for initial screening and blood tests every two weeks.
Who is the study for?
This trial is for melanoma patients with no current disease, resected within the last 5 years. Participants must have a BMI of 18.5-40, normal kidney and liver function tests, fasting glucose under 125 mg/dL, and not be pregnant. They should agree to eat only provided diets and attend scheduled visits in Houston, TX.
What is being tested?
The study compares the effects of two diets on individuals with a history of melanoma: a whole-foods, fiber-rich diet versus a ketogenic diet. Participants will receive free food for six weeks and undergo regular blood tests to monitor changes.
What are the potential side effects?
While specific side effects are not listed for dietary interventions, participants may experience changes in digestion or energy levels due to alterations in their usual eating habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of conducting a controlled feeding study in melanoma patients
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group II (ketogenic diet)Experimental Treatment2 Interventions
Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.
Group II: Group I (fiber-rich diet)Experimental Treatment2 Interventions
Patients consume a whole-foods, fiber-rich diet for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,225 Total Patients Enrolled
108 Trials studying Melanoma
25,969 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,017,073 Total Patients Enrolled
564 Trials studying Melanoma
191,204 Patients Enrolled for Melanoma
Jennifer McQuadePrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Melanoma
50 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken antibiotics in the last month, as confirmed by you or your doctor.You have received treatment for melanoma in the past year.You have significant dietary restrictions that relate to the study treatment.You have been diagnosed with type I or type II diabetes and need medicine to treat it.Your body mass index (BMI) is between 18.5 and 40.Your creatinine level in the blood is less than 1.5 mg/dL.Your liver function tests show levels that are two times higher than normal.Your blood sugar level when you haven't eaten should be less than 125 mg/dL.You are currently on a very high-fat diet, consuming a lot of fiber every day, or following a vegetarian or vegan diet.Women who could become pregnant must have a negative pregnancy test within one week before the DEXA scan.You smoke, drink heavily (more than 14 drinks per week), or use illegal drugs.You have been taking certain supplements or medications for weight loss or bodybuilding in the last 30 days.Your LDL cholesterol level is higher than 200 mg/dL within the last 28 days.Your triglyceride levels are higher than 350 mg/dL within the past 28 days.You had melanoma removed within the last 5 years and currently don't have any signs of the disease.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (fiber-rich diet)
- Group 2: Group II (ketogenic diet)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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