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Dietary Intervention in Patients With a History of Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950635
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : July 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Dietary Supplement: Dietary Intervention Other: Questionnaire Administration Not Applicable

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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, 2021
Estimated Study Completion Date : November 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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) 18.5-40 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).

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    
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: July 17, 2020
Last Verified: July 2020

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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