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Effect of Diet on the Immune System in Patients With Stage III-IV Melanoma Receiving Immunotherapy, DIET Study (DIET)

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ClinicalTrials.gov Identifier: NCT04645680
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : September 22, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 16, 2020
First Posted Date  ICMJE November 27, 2020
Last Update Posted Date September 22, 2022
Actual Study Start Date  ICMJE June 24, 2020
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2020)
  • Change in systemic and tumor immunity [ Time Frame: Up to 12 weeks ]
    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.
  • Change in metabolic profile [ Time Frame: Baseline up to 11 weeks ]
    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.
  • Change in quality of life (QOL) [ Time Frame: Baseline up to 11 weeks ]
    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.
  • Incidence of adverse events [ Time Frame: Up to 12 weeks ]
    AEs attributed to diet as well as immune-related adverse events (irAEs) attributed to immunotherapy will be assessed using frequency counts and percentages.
  • Symptom profile [ Time Frame: Up to 12-week follow-up ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 25, 2020)
  • Objective response rate (ORR) (unresectable cohort) [ Time Frame: At 12-week follow-up ]
    Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The ORR will be estimated along with 95% confidence interval, and compared between two diet groups using Chi-squared test or Fisher's exact test as appropriate.
  • Progression-free survival (PFS) (unresectable cohort) [ Time Frame: Up to 12-week follow-up ]
    Response will be assessed by RECIST 1.1. PFS will be assessed using Kaplan-Meier method and compared between two diet groups using log-rank test.
  • Recurrence rate (RR) (adjuvant cohort) [ Time Frame: Up to 12-week follow-up ]
    Response will be assessed by RECIST 1.1. The RR will be estimated along with 95% confidence interval, and compared between two diet groups using Chi-squared test or Fisher's exact test as appropriate.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Diet on the Immune System in Patients With Stage III-IV Melanoma Receiving Immunotherapy, DIET Study
Official Title  ICMJE Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy
Brief Summary This phase II trial investigates the possible immune effects of two different diets targeting the gut microbiome in patients with stage III-IV melanoma that has been removed by surgery (resectable), has spread to other places in the body (metastatic), or is unable to be removed by surgery (unresectable), and who are being treated with the immunotherapy drugs pembrolizumab or nivolumab as part of their standard of care. Both diets are whole foods diets that meet the American Cancer Society recommendations for cancer patients, but they will vary in fiber content. The purpose of this trial is to learn about the effects of dietary interventions on the structure and function of the gut microbiome in patients with melanoma being treated with standard of care immunotherapy (pembrolizumab or nivolumab).
Detailed Description

PRIMARY OBJECTIVE:

To establish the effects of dietary intervention on the structure and function of the gut microbiome.

SECONDARY OBJECTIVES:

  1. Assess the effects of dietary intervention on gut metabolic output and systemic metabolism.
  2. Assess the effects of dietary intervention on systemic and tumor immunity
  3. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention
  4. Assess the rate of immune related adverse events in patients on immunotherapy receiving dietary interventions
  5. Determine the maximum daily fiber content that 70% of participants are able to tolerate
  6. 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)
  7. Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs)

EXPLORATORY OBJECTIVES:

  1. 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).
  2. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Participants will be blinded to their assigned diet throughout the intervention as will the investigators and research staff with the exception of the dietitian and the staff performing group assignment and data entry who will not have contact with participant
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Other: Dietary Intervention
    Consume isocaloric whole foods diet higher in fiber
    Other Names:
    • Dietary Modification
    • intervention, dietary
    • Nutrition Intervention
    • Nutrition Interventions
    • Nutritional Interventions
  • Other: Dietary Intervention
    Whole foods diet
    Other Names:
    • Dietary Modification
    • intervention, dietary
    • Nutrition Intervention
    • Nutrition Interventions
    • Nutritional Interventions
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Other: Dietary Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Active Comparator: Arm II (isocaloric diet)
    Patients receive a standard whole foods diet recommended by the American Cancer Society for 11 weeks.
    Interventions:
    • Other: Dietary Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2020)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Body mass index (BMI) 18.5-40 kg/m^2
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. English-speaking
  5. Self-reported willingness to exclusively eat the provided diets
  6. Self-reported willingness to comply with scheduled visits, undergo venipuncture, and provide stool samples
  7. Cohort-specific:

Unresectable:

i. Histologically confirmed unresectable stage III or stage IV melanoma ii. Currently receiving therapy with standard of care anti-PD1 immunotherapy. Initial induction with anti-CTLA4 and anti-PD1 is allowed iii. Stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as best response while on anti-PD1 >= 6 months for metastatic melanoma with plan to continue anti-PD1 iv. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version [v]1.1; i.e., defined as at least 1 lesion that can be accurately measured in at least 1 dimension [longest diameter to be recorded] with a minimum size of >= 10 mm by computerized tomography [CT] scan or caliper measurement on clinical exam)

  1. Participants must have at least one lesion amenable to biopsy that has not been previously irradiated
  2. Participants must be willing to undergo a newly-obtained core needle or incisional biopsy at baseline. Fine needle aspiration is not acceptable

Adjuvant:

i. Resected stage II-IV melanoma with planned initiation of adjuvant anti-PD1 +/- anti-CTLA4

Neoadjuvant:

i. Histologically confirmed stage III/IV melanoma with planned initiation of neoadjuvant anti-PD1 + anti-CTLA4

1. Participants must be willing to undergo a newly-obtained core needle or incisional biopsy at baseline. Fine needle aspiration is not acceptable.

Exclusion Criteria:

  1. History of >= grade II colitis or diarrhea on immunotherapy or any ongoing colitis or diarrhea of any grade
  2. Unresolved >= grade III immune-related adverse event on immunotherapy (other than endocrinopathy requiring hormone replacement)
  3. 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).
  4. Medical contraindications to intervention diet as determined by the treating physician
  5. Self-reported major dietary restrictions related to the intervention
  6. Diagnosis of diabetes mellitus type I or type II that requires medical treatment or random glucose > 200 mg/dL
  7. Antibiotic use within 21 days of planned start of equilibration diet (self-reported and/or noted by the treating physician)
  8. 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
  9. 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
  10. Currently consuming an average estimated daily fiber intake exceeding 20 grams based on the results of the preliminary dietary assessment; vegetarian or vegan
  11. Current smoker or heavy drinker (defined as > 14 drinks per week) or current self reported illicit drug use
  12. Uncontrolled concurrent illness or infection or psychiatric illness/social situations that would limit compliance with study requirements
  13. Unable or unwilling to undergo study procedures
  14. Plan for travel during the study that would preclude adherence to prescribed diets
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer McQuade 713-745-9947 jmcquade@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04645680
Other Study ID Numbers  ICMJE 2020-0158 (PA17-0104)
NCI-2020-06112 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0158 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party M.D. Anderson Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE M.D. Anderson Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jennifer McQuade M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP