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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

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.

Condition or disease Intervention/treatment Phase
Melanoma No Evidence of Disease Dietary Supplement: Dietary Intervention Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Controlled Dietary Interventions in Patients With Melanoma
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : November 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Group I (fiber-rich diet)
Patients consume a whole-foods, fiber-rich diet for 6 weeks.
Dietary Supplement: Dietary Intervention
Consume whole-foods, fiber-rich diet
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Questionnaire Administration
Ancillary studies

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) 18.5-35 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950635


Contacts
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Contact: Jennifer McQuade 713-792-2921 jmcquade@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer McQuade    713-792-2921      
Principal Investigator: Jennifer McQuade         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jennifer McQuade M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03950635     History of Changes
Other Study ID Numbers: 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 )
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas