NCT06376604

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: L-Nutra Inc · Industry
• Sex: Female
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

Detailed description

Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.

Conditions

• Cancer, Ovarian
• Chemotherapy Effect
• Calorie Deficiency
• Fasting, Intermittent

Interventions

Type	Name	Description
OTHER	Fasting Mimicking Diet	Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.
DRUG	Chemotherapy	6 cycles of standard chemotherapy for the gynecologic malignancy.

Timeline

• Start date: 2021-09-08
• Primary completion: 2025-09-01
• Completion: 2025-12-30
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: United States