~44 spots leftby Dec 2029

Fasting-Mimicking Diet and Immunotherapy for Non-Small Cell Lung Cancer

(Stage IV NSCLC Trial)

Recruiting in Palo Alto (17 mi)
+3 other locations
Shadia I. Jalal, MD | IU Health
Overseen byShadia Jalal, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.

Eligibility Criteria

This trial is for individuals with Non-Small Cell Lung Cancer who are currently receiving maintenance immunotherapy. The study aims to understand how a special diet that mimics fasting affects cancer treatment.

Inclusion Criteria

I have been newly diagnosed with stage IV NSCLC or have advanced NSCLC not eligible for standard treatment but can join a trial.
I am 18 years old or older.
Ability to provide written informed consent and HIPAA authorization
+4 more

Exclusion Criteria

I have lost more than 10% of my weight in the last 6 weeks.
I have been treated with drugs targeting IGF-1 like Linsitinib.
Significant food allergies which would make the subject unable to consume the food provided
+5 more

Participant Groups

Participants will either continue their regular diet or switch to a Fasting Mimicking Diet (FMD) while undergoing their standard immunotherapy treatments. The goal is to see if the FMD can improve the effectiveness of the therapy.
2Treatment groups
Experimental Treatment
Active Control
Group I: FMDExperimental Treatment2 Interventions
Plant based diet program.
Group II: Regular DietActive Control1 Intervention
Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
VA Central California Health Care System, Fresno, CAFresno, CA
VA Long Beach Healthcare System, Long Beach, CALong Beach, CA
Jesse Brown VA Medical Center, Chicago, ILChicago, IL
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, IN
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Who Is Running the Clinical Trial?

VA Office of Research and DevelopmentLead Sponsor
Indiana UniversityCollaborator
US Department of Veterans Affairs Cooperative Studies ProgramCollaborator
L-Nutra IncIndustry Sponsor

References