Fasting Mimicking Diet + Chemotherapy for Ovarian Cancer

Overseen by Mary T Jenkins Vogel, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Endeavor Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests whether a special diet that mimics fasting can help reduce the severe side effects of chemotherapy in patients with advanced ovarian, fallopian tube, and primary peritoneal cancer. The diet aims to protect the body while still allowing the chemotherapy to work effectively. Previous studies have shown that this diet can reduce nausea and improve treatment outcomes.

Research Team

Mary T Jenkins Vogel, MD

Principal Investigator

Endeavor Health

Eligibility Criteria

This trial is for adults over 18 with advanced or recurrent ovarian, fallopian tube, and primary peritoneal cancers suitable for chemotherapy. Participants must have been platinum-sensitive if recurrent, have a good performance status (able to carry out daily activities), normal blood counts and organ function, and a BMI of at least 19. Those with malnutrition, eating disorders, diabetes needing medication or allergies to the diet's components cannot join.

Inclusion Criteria

My kidney function is normal, based on my creatinine levels.

I am 18 years old or older.

My blood tests show enough white blood cells and platelets.

Exclusion Criteria

You have been diagnosed with an active eating disorder.

You are underweight or have poor nutrition.

You are allergic to any part of the fasting mimicking diet (FMD).

Treatment Details

Interventions

• Carboplatin (Chemotherapy)
• Fasting Mimicking Diet (FMD) (Behavioural Intervention)
• Paclitaxel (Chemotherapy)

Trial Overview The study examines if combining a Fasting Mimicking Diet (FMD) with standard chemotherapy drugs Paclitaxel and Carboplatin reduces toxicity and improves tumor response in patients compared to those on a regular diet during treatment. The FMD product used is Xentigen by L'Nutra.

Participant Groups

Group I: Carboplatin and paclitaxel with fasting mimicking diet (FMD) Experimental Treatment 3 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A fasting mimicking diet (FMD) is consumed beginning 3 days prior to chemotherapy and on the day of chemotherapy (days -2, -1, 0 and 1 of each cycle).

Group II: Carboplatin and paclitaxel with standard diet Active Control 3 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A standard diet is consumed throughout each cycle of therapy.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Gerald "J.P." Gallagher

Endeavor Health

Chief Executive Officer since 2022

MBA from Benedictine University

Sanjeeb Khatua, MD

Endeavor Health

Chief Physician Executive since 2023

MD from Rush Medical College

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

David Hall

NorthShore University HealthSystem

Chief Executive Officer since 2009

MBA in Healthcare Management, Western Governors University

Dr. Andi Arnautovic

NorthShore University HealthSystem

Chief Medical Officer since 1989

Residency at Mount Sinai Hospital, Chicago

L-Nutra Inc

Industry Sponsor

Trials

10

Recruited

730+