MelanomaPhase 1NCT03950635
Dietary Intervention in Patients with a History of Melanoma
A Phase 1 study testing Dietary Intervention and Questionnaire Administration in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Dietary Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 27 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Dietary Interventions in Patients with Melanoma
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.
Read the detailed description
Study Background:
Whole-foods, fiber-rich diet rationale: Recent studies have shown that the gut microbiome (the trillions of bacteria that live in our intestines) can influence our immune system function. Diet plays a key role in shaping the gut microbiome. We will examine the effects of a whole-food, fiber-rich diet on the gut microbiome within patients with a history of melanoma.
Ketogenic diet rationale: The ketogenic diet is a very-low-carbohydrate, high-fat diet. The goal of this diet is to change the body's fuel source from carbohydrates to fat and to lower levels of insulin. We will examine the effects of a ketogenic diet to change metabolism within patients with a history of melanoma.
Who can participate?
To be eligible for the study, participants must meet the following criteria:
- Be at least 18 years old;
- Meet the study requirements for Body Mass Index (BMI);
- Have had melanoma within the last 5 years;
- Be cancer-free at the start of the trial;
- Have not received systemic therapy within the last year; and
- Have no medical issues that would make them unable to follow these eating plans.
Study Design:
Our study will enroll up to 10 participants to each diet (high-fiber or ketogenic). After screening, participants will have baseline assessment performed that will include collecting diet information, blood and fecal samples, and body composition information. Participants will then eat the provided diets for the next 6 weeks while coming in every 2 weeks for blood and stool specimen collection. Six (6)weeks after the diet intervention is complete, participants will come back to MD Anderson for one last end of study visit.
Who makes the meals?:
All calorie-containing food and beverages will be provided by either the MD Anderson Cancer Center Bionutrition Research Core or Savor Health (a third-party vendor contracted by MD Anderson).
Costs: There will be no cost to participate in this study.
Benefits:
All food and beverages you will eat as part of this study will be provided by the study and can be shipped directly to your home. The results will be used to help us design future dietary intervention trials in Melanoma patients receiving immunotherapy. Please note, participants can withdraw from the study at any time without consequences.
Study PI: Dr. Jennifer McQuade
NCT#: NCT03950635
Contact Info:
Melanoma Medical Oncology (713)-792-5500 MelanomaDiet@mdanderson.org
Where: MD Anderson Cancer Center, Department of Melanoma Medical Oncology, Houston, TX
- Conditions
- Melanoma
- Being tested
- Dietary Intervention, Questionnaire Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Consume whole-foods, fiber-rich diet
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Consume high fat, low carbohydrate (ketogenic) diet
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (fiber-rich diet) | Experimental | Patients consume a whole-foods, fiber-rich diet for 6 weeks. Receives: Dietary Supplement: Dietary Intervention; Other: Questionnaire Administration |
| Group II (ketogenic diet) | Experimental | Patients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks. Receives: Dietary Supplement: Dietary Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting a controlled feeding study in melanoma patients
Defined by >= 25% of eligible patients enrolling on the protocol.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start16 Apr 2019
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Why it stopped: Administratively Complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer McQuade, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950635
- Sponsor's protocol ID
- 2018-0857
- Other IDs
- NCI-2019-02496, 2018-0857
- Status last verified
- Dec 2024
- First submitted
- 6 May 2019
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Dietary Interventions in Patients with Melanoma
- ClinicalTrials.gov ID
- NCT03950635
- Acronym / sponsor ID
- 2018-0857
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively Complete
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Background:
Whole-foods, fiber-rich diet rationale: Recent studies have shown that the gut microbiome (the trillions of bacteria that live in our intestines) can influence our immune system function. Diet plays a key role in shaping the gut microbiome. We will examine the effects of a whole-food, fiber-rich diet on the gut microbiome within patients with a history of melanoma.
Ketogenic diet rationale: The ketogenic diet is a very-low-carbohydrate, high-fat diet. The goal of this diet is to change the body's fuel source from carbohydrates to fat and to lower levels of insulin. We will examine the effects of a ketogenic diet to change metabolism within patients with a history of melanoma.
Who can participate?
To be eligible for the study, participants must meet the following criteria:
- Be at least 18 years old;
- Meet the study requirements for Body Mass Index (BMI);
- Have had melanoma within the last 5 years;
- Be cancer-free at the start of the trial;
- Have not received systemic therapy within the last year; and
- Have no medical issues that would make them unable to follow these eating plans.
Study Design:
Our study will enroll up to 10 participants to each diet (high-fiber or ketogenic). After screening, participants will have baseline assessment performed that will include collecting diet information, blood and fecal samples, and body composition information. Participants will then eat the provided diets for the next 6 weeks while coming in every 2 weeks for blood and stool specimen collection. Six (6)weeks after the diet intervention is complete, participants will come back to MD Anderson for one last end of study visit.
Who makes the meals?:
All calorie-containing food and beverages will be provided by either the MD Anderson Cancer Center Bionutrition Research Core or Savor Health (a third-party vendor contracted by MD Anderson).
Costs: There will be no cost to participate in this study.
Benefits:
All food and beverages you will eat as part of this study will be provided by the study and can be shipped directly to your home. The results will be used to help us design future dietary intervention trials in Melanoma patients receiving immunotherapy. Please note, participants can withdraw from the study at any time without consequences.
Study PI: Dr. Jennifer McQuade
NCT#: NCT03950635
Contact Info:
Melanoma Medical Oncology (713)-792-5500 MelanomaDiet@mdanderson.org
Where: MD Anderson Cancer Center, Department of Melanoma Medical Oncology, Houston, TX
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (fiber-rich diet) | Experimental | Dietary Supplement: Dietary Intervention, Other: Questionnaire AdministrationPatients consume a whole-foods, fiber-rich diet for 6 weeks. |
| Group II (ketogenic diet) | Experimental | Dietary Supplement: Dietary Intervention, Other: Questionnaire AdministrationPatients consume a high fat, low carbohydrate (ketogenic) diet for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsConsume whole-foods, fiber-rich diet | Dietary supplement | Group I (fiber-rich diet) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsConsume high fat, low carbohydrate (ketogenic) diet | Dietary supplement | Group II (ketogenic diet) |
| Questionnaire AdministrationAncillary studies | Other | Group I (fiber-rich diet), Group II (ketogenic diet) |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Administratively Complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
- https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0857.htmlLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer McQuade principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dietary Intervention and Questionnaire Administration in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively Complete). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of conducting a controlled feeding study in melanoma patients (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.