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Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer | Clinical Trials | Clareo Health

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

A Randomized Controlled Study of a Fasting Mimicking Diet (FMD) in Conjunction With Combination Carboplatin and Paclitaxel in the Treatment of Patients With Advanced or Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer

NCT05921149•Endeavor Health

View on ClinicalTrials.gov

Summary

Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed. Short term fasting protects against toxic effects of chemotherapy without decreasing efficacy. In a prospective clinical trial of breast cancer patients randomized to FMD or regular diet during chemotherapy, less antiemetic was required in the FMD group; radiographic and pathologic responses were better in this group. This trial tests whether platinum-taxane chemotherapy combined with a FMD in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer patients is associated with decreased toxicity and/ or improved tumor response to therapy.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years
•2. All patients with advanced ovarian, fallopian tube and primary peritoneal carcinomas deemed appropriate candidates for neoadjuvant chemotherapy and patients with recurrent, platinum-sensitive disease (as defined by an interval of at least 6 months following completion of last platinum-based chemotherapy prior to disease relapse or progression)
•3. ECOG Performance Status of 0, 1 or 2.
•4. Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109/L and platelet count ≥100 x 109/L).
•5. Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN).
•6. Adequate hepatic function defined as:
•Bilirubin ≤1.5 x ULN ALT and AST ≤3 x ULN
•7. BMI ≥19 kg/m2

Exclusion Criteria

•1. Patients with malnutrition and/ or BMI \<19
•2. Patients with active eating disorders (as identified by history of pre-enrollment nutrition screen)
•3. Diabetes mellitus requiring medication management (both insulin and non-insulin requiring). Patients with diabetes mellitus controlled by diet alone (i.e. patients not requiring anti-glycemic medications) are NOT excluded and are eligible for participation.
•4. Allergy to component of fasting mimicking diet (FMD)
•5. Patients with recurrent ovarian, fallopian tube and primary peritoneal carcinomas with relapse within 6 months of completion of last platinum-based chemotherapy regimen (i.e. patients with platinum-resistant disease)

Locations (1)

NorthShore University HealthSystem

Evanston, Illinois, United States

Key Dates

Start Date

May 25, 2024

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2031

Last Updated

May 7, 2024

Enrollment

170

ESTIMATED participants

Conditions

Ovarian CancerChemotherapeutic Toxicity

Interventions

Fasting Mimicking Diet (Xentigen by L'Nutra)

DIETARY_SUPPLEMENT

Carboplatin

DRUG

Paclitaxel

DRUG

Standard diet

DIETARY_SUPPLEMENT

Contacts

Michele Britto, RN

CONTACT

(847) 570-2109 mbritto@northshore.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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