Dietary Intervention in Patients with a History of Melanoma

NCT03950635 | Terminated Phase 1

• 2 other identifiers: 2018-0857NCI-2019-02496
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of conducting a controlled feeding study in melanoma patients

  Defined by \>= 25% of eligible patients enrolling on the protocol.

  Up to 1 year

Study Arms (2)

Group I (fiber-rich diet)

EXPERIMENTAL

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

Dietary Supplement: Dietary Intervention; Other: Questionnaire Administration

Group II (ketogenic diet)

EXPERIMENTAL

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

Dietary Supplement: Dietary Intervention; Other: Questionnaire Administration

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Consume whole-foods, fiber-rich diet

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Group I (fiber-rich diet)

Questionnaire Administration OTHER

Ancillary studies

Group I (fiber-rich diet); Group II (ketogenic diet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website
• https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0857.html

MeSH Terms

Conditions

Melanoma

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Jennifer McQuade

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 15, 2019
• Study Start: April 16, 2019
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (1)