Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

L-Nutra

Status: Enrolling

Conditions: Chemotherapy Effect; Cancer, Ovarian; Fasting, Intermittent; Calorie Deficiency

Treatments: Drug: Chemotherapy; Other: Fasting Mimicking Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06376604

LNT55

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women
• Age 35-70 years old (both inclusive)
• Biopsy proven gynecologic malignancy
• Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
• BMI greater than or equal to 18.5
• Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
• Willing to adhere to a 5-day fasting mimicking diet

Exclusion criteria

• Pregnant or nursing mothers
• Prisoners
• Patients with diabetes or history of hypoglycemia
• Taking daily medications that cannot be safely taken without food
• History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
• Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
• Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

FMD

Experimental group

Description:

In addition to the standard care, subject will consume a 5-day fasting mimicking diet.

Treatment:

Drug: Chemotherapy

Other: Fasting Mimicking Diet

Control

Active Comparator group

Description:

Subjects will receive the standard care and no dietary changes.

Treatment:

Drug: Chemotherapy