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

NANot yet recruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

May 25, 2024

Primary Completion Date

June 1, 2028

Study Completion Date

June 1, 2031

Conditions
Ovarian CancerChemotherapeutic Toxicity
Interventions
DIETARY_SUPPLEMENT

Fasting Mimicking Diet (Xentigen by L'Nutra)

L-Nutra Xentigen is a product which will provide all the food to be consumed by subjects during 3 days prior to chemotherapy and for 24 hours after chemotherapy. Xentigen is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients that are generally regarded as safe (GRAS) and comprises proprietary vegetable-based soups and broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. The FMD consists of a 4-day regimen that provides approximately 1100 kilocalories for the first day and approximately 500 kilocalories per day for the second to the fourth day. Subsequently, a day 5 of transition diet (approximately 800 kilocalories) is provided to avoid the refeeding syndrome.

DRUG

Carboplatin

Given IV

DRUG

Paclitaxel

Given IV

DIETARY_SUPPLEMENT

Standard diet

Normal diet

Trial Locations (1)

60201

NorthShore University HealthSystem, Evanston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

L-Nutra Inc

INDUSTRY

lead

Endeavor Health

OTHER

NCT05921149 - Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer | Biotech Hunter | Biotech Hunter