Cancer Nutrition Study - A Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors

NCT07804225 | Not Yet Recruiting DMC

• 2 other identifiers: iRISID-2026-1168JT 48688
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether changing the diet can help improve gut health and support recovery from immune-related side effects caused by immune checkpoint inhibitor (ICI) cancer treatment in adults with solid tumors who develop moderate to severe immune-related side effects that require steroid treatment. The main questions it aims to answer are: Does a high-fermented food diet or a high-fiber resistant starch supplement change the gut microbiome (the bacteria and other microorganisms that live in the digestive tract) during treatment? Does either dietary approach improve gut microbiome diversity and function by the end of the 7-week intervention period? Researchers will compare participants assigned to a high-fermented food diet with participants assigned to high-fiber resistant starch supplementation to see if one approach leads to greater improvements in the gut microbiome and related biological measures. Participants will: Be randomly assigned to 1 of 2 dietary intervention groups: High-fermented food diet High-fiber resistant starch supplement Follow their assigned diet for 7 weeks, starting when their ICI treatment is restarted. Provide stool samples before the intervention begins and regularly throughout the study. Have blood samples collected at the start of the study and approximately every 3 to 4 weeks during participation. Provide skin and mouth swab samples at the beginning of the study and again at Week 7. Complete food diaries and symptom assessments during the study. Participate in a 2-week follow-up period after completing the dietary intervention. Researchers will also evaluate the safety of the dietary interventions, whether immune-related side effects return, how the immune system responds, and how closely participants follow their assigned diet.

Conditions

Solid Tumor Cancer; Immune-Related Adverse Events

Keywords

Immune Checkpoint Inhibitors; Gut Microbiome; Food Log; Food Diet; High-Fiber Supplementation; High-Fermented Food Diet

Outcome Measures

Primary Outcomes (1)

• Change in Gut Microbiota composition

  To longitudinally assess changes in gut microbiota composition, in patients with solid tumors who develop grade ≥2 irAEs during ICI therapy and undergo dietary modification with either high-fermented foods (Arm 1) or high-fiber supplementation (Arm 2).

  Baseline through Week 7

Secondary Outcomes (5)

• Incidence of Adverse Events related to dietary intervention

  Baseline throguh Week 9 (approximately 11 weeks)

• Tolerability of the dietary intervention

  Baseline throguh Week 9 (approximately 11 weeks)

• Incidence of new immune-related adverse events following ICI re-initiation

  12 months

• Changes in Circulating Immune Cells

  Baseline, Weeks 4, 7, and Week 8-9

• Changes in Circulating Inflammatory Markers

  Baseline, Weeks 4, 7, and Week 8-10

Study Arms (2)

Arm 1: High-Fermented Food Diet - HFFD

EXPERIMENTAL

Participants will consume a high-fermented food diet consisting of at least 6 servings of fermented foods per day for 7 weeks.

Behavioral: High-Fermented Food Diet

Arm 2: High-Fiber Supplementation - HFS

EXPERIMENTAL

Participants will receive HI-MAIZE 260 resistant starch supplementation for 7 weeks.

Dietary Supplement: HI-MAIZE 260 Resistant Starch

Interventions

High-Fermented Food Diet BEHAVIORAL

Participants will consume a high-fermented food diet consisting of at least 6 servings of fermented foods per day for 7 weeks. Participants will receive dietary counseling and regular follow-up with a nutritionist to support adherence to the assigned dietary intervention.

Arm 1: High-Fermented Food Diet - HFFD

HI-MAIZE 260 Resistant Starch DIETARY_SUPPLEMENT

Participants will receive HI-MAIZE 260, high-amylose cornstarch resistant starch dietary fiber supplement, daily for 7 weeks. Participants will receive dietary counseling and regular follow-up with a nutritionist to support adherence to the assigned dietary intervention.

Arm 2: High-Fiber Supplementation - HFS

Eligibility Criteria

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

You may qualify if:

• Be willing and able to provide written informed consent.
• Adult ≥ 18 years of age, willing and able to provide blood and stool specimen and comply with dietary modification, as well as willing to fill out study required questionnaires (paper or electronic and web-based).
• Patients must have any type of electronic device such as a smartphone, tablet, or computer, etc. that can access the internet.
• Self-reported willingness to adhere with dietary intervention.
• Self-reported willingness to comply to scheduled follow ups, fill out questionnaires/food logs, provide stool samples and undergo venipuncture.
• Patients who are actively receiving ICIs and remain on this during the dietary intervention period (anti-PD-1/PD-L1, anti-CTLA4, anti-LAG3 or other immunotherapy that is currently FDA approved or listed in NCCN or ASCO guidelines for treatment of any solid malignancy, for example if patient is enrolled in clinical trial, studying pebrolizumab in any solid malignancy for new indication, these patients can be enrolled in this trial, given safety and efficacy of this ICI is well studied and approved in multiple settings) will be consented for the dietary intervention study.
• Any solid tumor (e.g., lung, melanoma, breast, head and neck, etc.) patients with grade ≥2 cutaneous (rash, dermatitis etc), constitutional (fatigue),rheumatological (arthralgia, arthritis) or GI (colitis, diarrhea, enteritis) irAEs while treated with ICIs i. Treated with topical steroids ii. Treated with systemic steroids or other immunemodulators iii. Are willing and able to continue ICIs concomitant with dietary intervention

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Use of systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral) within the last 14 days
• Use of oral, intravenous, intramuscular, nasal, or inhaled 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:
• Cytokines
• Methotrexate or immunosuppressive cytotoxic agents, unless the regimen is deemed appropriate by the study investigator (e.g., use of low-dose hydroxychloroquine may be permitted at the investigator's discretion)
• Regularly taking probiotics, fiber supplements, or any other medication or prebiotic dietary supplement that could affect the study outcome as determined by the principal investigator and unable/unwilling to discontinue for the study. These agents must be discontinued at least 14 days prior to the start of the diet
• Current use of chronic alcohol within the last 4 weeks, defined as more than five 1.5-ounce servings of 80-proof distilled spirits, five 12-ounce servings of beer, or five 5-ounce servings of wine per day
• Current consumption of fiber \>30g (determined based on patient-reported intake or baseline questionnaire assessment \[DHQ3 or ASA24\]) or fermented food \>3 portions a day (foods/drinks tested in the clinical trial: kefir, buttermilk, kimchi, sauerkraut, brine drinks, and kombucha)
• Any major bowel resection at any time. If patient had partial bowel resection ≥1 year ago, may be permitted at the investigator's discretion
• 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
• Systemic antibiotics and proton pump inhibitors (PPIs) are not allowable during the study (should be discontinued \>14 days prior). If PPIs or systemic antibiotics are initiated by the patient's treating physician, the patient should report this to the study team during the study period
• o Note: Administration of antibiotics for procedural purposes such as during wide local excision of a tumor, lymph node biopsy, or similar interventions will not be considered a protocol deviation but must be reported and documented
• Unable or unwilling to adhere to scheduled interventions and study procedures
• Patient with life-threatening irAEs including but not limited to myocarditis, encephalitis, or vasculitis

Sponsors & Collaborators

• Thomas Jefferson University: lead

MeSH Terms

Interventions

high-amylose maize type 2 resistant starch, maize

Study Officials

• Khvaramze Shaverdashvili, M.D. PhD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Site Public Contact

CONTACT

215-600-9151; ONCTrialNow@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 4, 2026

Record last verified: 2026-08