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Chemotherapy

Fasting Mimicking Diet + Chemotherapy for Ovarian Cancer

N/A

Waitlist Available

Led By Mary T Jenkins Vogel, MD

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

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

Must have

Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN)

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 and 5 years

Awards & highlights

Study Summary

This trial tests if fasting can reduce side effects of chemotherapy and improve results in ovarian cancer patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Chemotherapy can cause severe side effects like fatigue, nausea/vomiting, low blood cell counts leading to infection risk or bleeding problems. The FMD aims to reduce these without affecting the cancer-fighting benefits of chemo.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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My blood tests show enough white blood cells and platelets.

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I have advanced ovarian, fallopian tube, or peritoneal cancer and am a candidate for initial chemotherapy.

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My liver tests are within the normal range.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased gastrointestinal (GI) toxicity in advanced and recurrent ovarian cancer patients.

To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased hematologic toxicity in advanced and recurrent ovarian cancer patients.

To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased neurotoxicity in advanced and recurrent ovarian cancer patients.

+3 more

Secondary outcome measures

To compare radiographic tumor response to therapy in advanced and recurrent ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.

To compare tumor pathologic response to therapy in advanced ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.

To compare tumor response to therapy using a serum biomarker in advanced and recurrent ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Carboplatin and paclitaxel with fasting mimicking diet (FMD)Experimental Treatment3 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 dietActive Control3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

L-Nutra IncIndustry Sponsor

8 Previous Clinical Trials

494 Total Patients Enrolled

1 Trials studying Ovarian Cancer

30 Patients Enrolled for Ovarian Cancer

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,488 Total Patients Enrolled

Mary T Jenkins Vogel, MDPrincipal InvestigatorNorthShore University HealthSystem

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05921149 — N/A

Ovarian Cancer Research Study Groups: Carboplatin and paclitaxel with fasting mimicking diet (FMD), Carboplatin and paclitaxel with standard diet

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05921149 — N/A

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05921149 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase for this medical study still ongoing?

"Clinicaltrials.gov confirms that this medical study, which was first posted on August 1st 2023 and most recently updated June 25th of the same year, is no longer actively recruiting patients. However, 693 other clinical trials are currently open for enrolment by prospective participants."

Answered by AI

Recent research and studies

BMC CancerJournal

Safety and Feasibility of Fasting in Combination with Platinum-based Chemotherapy

Dorff, Tanya B., Susan Groshen, Agustin Garcia, Manali Shah, Denice Tsao-Wei, Huyen Pham, Chia-Wei Cheng, et al.. 2016. “Safety and Feasibility of Fasting in Combination with Platinum-based Chemotherapy”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-016-2370-6.

clinicaltrials.govStudy

Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer

Tilley Jenkins-Vogel 2024. "Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05921149.