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

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

Interventions

BEHAVIORAL

High-Fermented Food Diet

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.

DIETARY_SUPPLEMENT

HI-MAIZE 260 Resistant Starch

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.

Sponsors & Collaborators

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• Khvaramze Shaverdashvili, M.D. PhD · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2029-06-30

Completion

2030-06-30