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Dietary Interventions for Cancer

N/A

Waitlist Available

Led By Hassane M Zarour, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

Early stage (I-III) resected melanoma patient on adjuvant immunotherapy

Must not have

Patients receiving ICIs enrolled in a clinical trial

Unable or unwilling to adhere schedule interventions and study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 weeks

Awards & highlights

Summary

This trial will investigate how different diets, focusing on high-fermented foods and high-fiber supplements, can impact the gut bacteria and immune response in patients with melanoma and lung cancer who are receiving

Who is the study for?

This trial is for melanoma and NSCLC cancer patients undergoing standard immune checkpoint inhibitor therapy. It's designed to see if certain diets can help their treatment work better.

What is being tested?

The study tests the effects of high-fermented foods and high-fiber supplements on gut bacteria and how they might boost the body's response to cancer immunotherapy in these patients.

What are the potential side effects?

Potential side effects may include digestive discomfort, such as bloating or gas, due to changes in diet with high-fermented foods and fiber supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have early-stage melanoma and am receiving immunotherapy after surgery.

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I have early stage lung cancer and am on adjuvant immunotherapy after surgery.

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I have early stage lung cancer and am getting chemo and immunotherapy before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in a clinical trial for immune checkpoint inhibitors.

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I am unable or unwilling to follow the study's schedule and procedures.

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I have not had major GI surgery in the last 5 years, except for gallbladder or appendix removal.

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I have not consumed more than five alcoholic drinks daily in the last 4 weeks.

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I do not have active, uncontrolled gut disorders like severe IBS or Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cell frequency of gut microbiota composition

Secondary study objectives

Adverse Events and Serious Adverse Events

Changes in cell frequency of circulating adaptive immune cells

Trial Design

1Treatment groups

Experimental Treatment

Group I: high-fermented food + high fiber supplementationExperimental Treatment2 Interventions

Step 1: patients will consume high-fermented food Step 2: High fiber supplementation

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,762 Previous Clinical Trials

16,347,943 Total Patients Enrolled

Hassane M Zarour, MDPrincipal InvestigatorUPMC Hillman Cancer Center

2 Previous Clinical Trials

29 Total Patients Enrolled

~40 spots leftby Jun 2027

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