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Dietary Intervention in Patients With a History of Melanoma

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ClinicalTrials.gov Identifier: NCT03950635
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : June 11, 2019
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 June 11, 2019
Actual Study Start Date  ICMJE April 16, 2019
Estimated Primary Completion Date November 29, 2019   (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 Complete list of historical versions of study NCT03950635 on ClinicalTrials.gov Archive Site
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 trial studies the effects of a fiber-rich diet or a ketogenic (high fat and low carbohydrate) diet in patients with a history of melanoma. A ketogenic diet provides daily calories through a high amount of fat and a very small amount of carbohydrates. A whole-foods, fiber-rich diet provides these calories through a diet based on fruits, vegetables, and whole grains. This study is being done to determine a tolerable diet "dose" by increasing the fiber content or fat content (ketogenic diet) over time and evaluating dietary compliance, tolerance, and biomarker change.
Detailed Description

PRIMARY OBJECTIVES:

I. Determine the feasibility of controlled dietary intervention studies in patients with history of melanoma.

SECONDARY OBJECTIVES:

I. Determine compliance with a controlled dietary intervention in patients with history of melanoma.

II. Determine the tolerance of dietary fiber and fat content. III. Determine the effects of controlled dietary interventions on metabolic parameters.

IV. Determine the effects of controlled dietary interventions on the fecal microbiome.

V. Examine the safety of controlled dietary interventions in patients with history of melanoma.

EXPLORATORY OBJECTIVES:

I. Explore the effects of controlled dietary intervention on systemic immunity. II. Explore the effects of controlled dietary intervention on oxidative stress. III. Explore changes in body composition with isocaloric dietary interventions. IV. Explore predictors of biological response (change in metabolic parameters and fecal microbiome) to dietary interventions.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients consume a whole-foods, fiber-rich diet for 6 weeks.

GROUP II: Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks.

Patients are followed up at 6 weeks after the end of study visit.

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
  • No Evidence of Disease
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, 2020
Estimated Primary Completion Date November 29, 2019   (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) 18.5-35 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 (within 21 days of screening).
  • Liver function tests (LFTs) 2 x upper limit of normal (ULN) (within 21 days of screening).
  • Fasting glucose < 125 mg/dL (within 21 days of screening).
  • Low density lipoprotein (LDL) < 160 mg/dL (within 21 days of screening).
  • Triglycerides < 200 mg/dL (within 21 days of screening).
  • 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 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.
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 June 2019

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