Clinical Stage III Cutaneous Melanoma AJCC v8Phase 2DIETNCT04645680
Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy
A Phase 2 study testing Dietary Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This is a randomized, double-blind, fully controlled feeding study that will enroll melanoma patients starting standard-of-care ICB in three settings: adjuvant, neoadjuvant, and unresectable. Patients are randomized to the high fiber or healthy control diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma
- What is being tested?
- Dietary Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2020to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old.
- Body mass index (BMI) 18.5-40 kg/m^2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- English-speaking
- Self-reported willingness to exclusively eat the provided diets
- Self-reported willingness to comply with scheduled visits, undergo venipuncture, and provide stool samples
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- Cohort-specific:
- 1 Adjuvant Melanoma: i. Resected Stage II-IV melanoma with planned initiation of adjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3
- 2 Unresectable Melanoma: i. Histologically confirmed unresectable stage III or Stage IV melanoma with planned initiation of standard of care anti-PD1 +/- CTLA4 or anti-PD1 +/- LAG3 immunotherapy and no prior immunotherapy in the metastatic setting.
- 3 Neoadjuvant Melanoma: i. Histologically confirmed stage III/IV melanoma with planned initiation of neoadjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 1. Participants must have archival tissue block available or be willing to undergo a newly-obtained core needle or incisional biopsy at baseline. Fine needle aspiration is not acceptable.
- 4 Unresectable RCC: i. Unresectable clear-cell renal cell carcinoma with planned initiation of standard of care anti-PD1 +/- anti-CTLA4 immunotherapy
Who cannot join
- History of >= grade II colitis or diarrhea on immunotherapy or any ongoing colitis or diarrhea of any grade
- Unresolved >= grade III immune-related adverse event on immunotherapy (other than endocrinopathy requiring hormone replacement)
- History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted).
- Medical contraindications to 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 or random glucose > 200 mg/dL
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- Antibiotic use within 21 days of planned start of equilibration diet (self-reported and/or noted by the treating physician)
- Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- Regularly taking probiotics, fiber supplements, or any other medication or supplement that could affect study outcome as determined by the principal investigator and unable/unwilling to discontinue for the purpose of the study. These agents must be discontinued at least 14 days prior to start of diet
- Currently consuming an average estimated daily fiber intake exceeding 20 grams based on the results of the preliminary dietary assessment; vegetarian or vegan
- Current smoker or heavy drinker (defined as > 14 drinks per week) or current self reported illicit drug use
- Uncontrolled concurrent illness or infection or psychiatric illness/social situations that would limit compliance with study requirements
- Unable or unwilling to undergo study procedures
- Plan for travel during the study that would preclude adherence to prescribed diets
- Cognitively impaired adults
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, double-blind, fully controlled feeding study that will enroll melanoma patients starting standard-of-care ICB in three settings: adjuvant, neoadjuvant, and unresectable. Patients are randomized to the high fiber or healthy control diet. The goal of the study is to establish the effects of dietary intervention on the structure and function of the gut microbiome in patients with melanoma treated with SOC immunotherapies.
Read the detailed description
PRIMARY OBJECTIVE:
To establish the effects of dietary intervention on the structure and function of the gut microbiome.
SECONDARY OBJECTIVES:
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism.
- Assess the effects of dietary intervention on systemic and tumor immunity
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention
- Assess the rate of immune related adverse events in patients on immunotherapy receiving dietary interventions
- Determine the maximum daily fiber content that 70% of participants are able to tolerate
- Assess the adherence to the dietary interventions as defined by 70% of calories consumed over the duration of the study being derived from provided diets (as measured by food records)
- Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs)
EXPLORATORY OBJECTIVES:
- Assess the association of dietary interventions with clinical outcomes (objective response rate [ORR] and progression-free survival [PFS] rate in unresectable cohort and recurrence rate [RR] in adjuvant cohort).
- Explore predictors of biological response to dietary interventions.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ISOCALORIC HIGH-FIBER DIET): Patients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks.
ARM II (ISOCALORIC CONTROL DIET): Patients receive a standard whole foods diet of recommended by the American Cancer Society for 11 weeks.
After completion of study, patients are followed up at 12 weeks.
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma
- Being tested
- Dietary Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Melanoma, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Consume isocaloric whole foods diet higher in fiber
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Whole foods diet
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (isocaloric high-fiber diet) | Experimental | Patients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks. Receives: Other: Dietary Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (isocaloric diet) | Active comparator | Patients receive a standard whole foods diet recommended by the American Cancer Society for 11 weeks. Receives: Other: Dietary Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the gut microbiome
Changes of alpha-diversity (e.g., Shannon index) and abundance/relative abundance of different taxon levels (e.g., genus, family), from baseline to end of intervention, will be estimated. The outcomes will be compared. between two arms using t-test or Mann-Whitney test. Linear mixed effects models will be used for assessing the longitudinal data. Similarity in microbiome community structure will be assessed using principal coordinate analysis (PCoA) and compared using multivariate analysis of variance (MANOVA).
Measured: Baseline up to 11 weeks
Secondary outcomes (5)
Change in systemic and tumor immunity
Percent change in CD8 T cells using flow cytometry will be compared between two arms using t-test or Mann-Whitney test. Pearson or Spearman correlation coefficient will be used to assess the correlation between the outcome at baseline and end of intervention.
Measured: Up to 12 weeks
Change in metabolic profile
Change in relative concentration (ion intensity determined as area under the curve) measured by mass spectrometry-based analysis of blood and fecal specimens from baseline to end of intervention will be compared between two arms using t-test or Mann-Whitney test.
Measured: Baseline up to 11 weeks
Change in quality of life (QOL)
Change in quality of life between baseline and end of intervention using a validated, 30 question scoring instrument (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Each question is scored in from 1 ("not at all") to 4 ("very much") in a Likert format. Linear mixed effects models will be used for assessing the longitudinal data. Pearson or Spearman correlation coefficient will be used to assess the correlation between measures for quality of life at baseline and end of intervention.
Measured: Baseline up to 11 weeks
Incidence of adverse events
AEs attributed to diet as well as immune-related adverse events (irAEs) attributed to immunotherapy will be assessed using frequency counts and percentages.
Measured: Up to 12 weeks
Symptom profile
To assess gastrointestinal symptoms related to the dietary interventions, the GSRS-IBS will be used. The GSRS-IBS is a 13-item validated instrument with subscales for each item ranging from 0 ("no discomfort at all") to 7 ("very severe discomfort"). The gastrointestinal symptoms (GSRS-IBS) will be summarized using frequency counts and percentages.
Measured: Up to 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start24 Jun 2020
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Stage III Cutaneous Melanoma AJCC v8Studies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- Erez Baruch, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645680
- Sponsor's protocol ID
- 2020-0158 (PA17-0104)
- Other IDs
- NCI-2020-06112, 2020-0158
- Acronym
- DIET
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2020
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farias RM, Jiang Y, Levy EJ, Hwang C, Wang J, Burton EM, Cohen L, Ajami N, Wargo JA, Daniel CR, McQuade JL. Diet and Immune Effects Trial (DIET)- a randomized, double-blinded dietary intervention study in patients with melanoma receiving immunotherapy. BMC Cancer. 2024 Dec 4;24(1):1493. doi: 10.1186/s12885-024-13234-1.
PubMed 39633321
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy
- ClinicalTrials.gov ID
- NCT04645680
- Acronym / sponsor ID
- DIET / 2020-0158 (PA17-0104)
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 27 Nov 2020 (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 is a randomized, double-blind, fully controlled feeding study that will enroll melanoma patients starting standard-of-care ICB in three settings: adjuvant, neoadjuvant, and unresectable. Patients are randomized to the high fiber or healthy control diet. The goal of the study is to establish the effects of dietary intervention on the structure and function of the gut microbiome in patients with melanoma treated with SOC immunotherapies.
Detailed description
PRIMARY OBJECTIVE:
To establish the effects of dietary intervention on the structure and function of the gut microbiome.
SECONDARY OBJECTIVES:
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism.
- Assess the effects of dietary intervention on systemic and tumor immunity
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention
- Assess the rate of immune related adverse events in patients on immunotherapy receiving dietary interventions
- Determine the maximum daily fiber content that 70% of participants are able to tolerate
- Assess the adherence to the dietary interventions as defined by 70% of calories consumed over the duration of the study being derived from provided diets (as measured by food records)
- Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs)
EXPLORATORY OBJECTIVES:
- Assess the association of dietary interventions with clinical outcomes (objective response rate [ORR] and progression-free survival [PFS] rate in unresectable cohort and recurrence rate [RR] in adjuvant cohort).
- Explore predictors of biological response to dietary interventions.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ISOCALORIC HIGH-FIBER DIET): Patients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks.
ARM II (ISOCALORIC CONTROL DIET): Patients receive a standard whole foods diet of recommended by the American Cancer Society for 11 weeks.
After completion of study, patients are followed up at 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (isocaloric high-fiber diet) | Experimental | Other: Dietary Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive a whole foods diet that follows the recommended American Cancer Society guidelines but is higher in fiber for 11 weeks. |
| Arm II (isocaloric diet) | Active comparator | Other: Dietary Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive a standard whole foods diet recommended by the American Cancer Society for 11 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old.
- Body mass index (BMI) 18.5-40 kg/m^2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- English-speaking
- Self-reported willingness to exclusively eat the provided diets
Key exclusion criteria (15 listed)
- History of >= grade II colitis or diarrhea on immunotherapy or any ongoing colitis or diarrhea of any grade
- Unresolved >= grade III immune-related adverse event on immunotherapy (other than endocrinopathy requiring hormone replacement)
- History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted).
- Medical contraindications to intervention diet as determined by the treating physician
- Self-reported major dietary restrictions related to the intervention
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 isocaloric whole foods diet higher in fiber | Other | Arm I (isocaloric high-fiber diet) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsWhole foods diet | Other | Arm II (isocaloric diet) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (isocaloric high-fiber diet), Arm II (isocaloric diet) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (isocaloric high-fiber diet), Arm II (isocaloric diet) |
Primary outcome
Change in the gut microbiome
Time frame: Baseline up to 11 weeks
Changes of alpha-diversity (e.g., Shannon index) and abundance/relative abundance of different taxon levels (e.g., genus, family), from baseline to end of intervention, will be estimated. The outcomes will be compared. between two arms using t-test or Mann-Whitney test. Linear mixed effects models will be used for assessing the longitudinal data. Similarity in microbiome community structure will be assessed using principal coordinate analysis (PCoA) and compared using multivariate analysis of variance (MANOVA).
5 secondary outcomes
Change in systemic and tumor immunity
Time frame: Up to 12 weeks
Change in metabolic profile
Time frame: Baseline up to 11 weeks
Change in quality of life (QOL)
Time frame: Baseline up to 11 weeks
Incidence of adverse events
Time frame: Up to 12 weeks
Symptom profile
Time frame: Up to 12-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 39633321Farias RM, Jiang Y, Levy EJ, Hwang C, Wang J, Burton EM, Cohen L, Ajami N, Wargo JA, Daniel CR, McQuade JL. Diet and Immune Effects Trial (DIET)- a randomized, double-blinded dietary intervention study in patients with melanoma receiving immunotherapy. BMC Cancer. 2024 Dec 4;24(1):1493. doi: 10.1186/s12885-024-13234-1.
- MD Anderson Cancer CenterLink 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.
Erez Baruch, MD,PHD 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 2 study testing Dietary Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, 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 11 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in the gut microbiome (time frame: Baseline up to 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645680, which also lists 1 linked publication.
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 30 Jan 2026.