Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

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

Subjects will receive the standard care and no dietary changes.

Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.

Fasting Mimicking Diet

6 cycles of standard chemotherapy for the gynecologic malignancy.

Chemotherapy

Min Wei, PhD

Jonathan D Boone, MD

Jonathan D Boone

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

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.

The study focuses on the chemotherapy of gynecologic malignancies.

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

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

The NFOSI-18 questionnaire allows for a uniform assessment of health-related quality of life through an 18-question (5-point Likert-type scale) survey including four subscale domains: Disease-Related Symptoms - Physical, Disease-Related Symptoms - Emotional, Treatment Side Effects. and Function/Well-Being. To calculate subscale scores, sum the item scores within each domain. Higher subscale scores indicate more significant symptom burden or impact. The total score is obtained by summing all 18 item scores. A higher total score reflects more severe symptoms overall.

The ability to adhere to a 5-day fasting mimicking diet.

Changes in weight, skeletal muscle mass, body fat percentage by the Inbody(R) Body Composition Analyzer.

Change in blood insulin like growth factor 1 level.

Change in blood C reactive protein level.

Deviation from the planned chemotherapy regimen.

Rate of Adverse effects associated with chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies	NCT06376604	Cancer, Ovarian Chemotherapy Ef... Calorie Deficie... Fasting, Interm...	Fasting Mimicki... Chemotherapy	35 Years - 70 Years	L-Nutra Inc
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies	NCT06376604	Cancer, Ovarian Chemotherapy Ef... Calorie Deficie... Fasting, Interm...	Fasting Mimicki... Chemotherapy	35 Years - 70 Years	L-Nutra Inc
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies	NCT06376604	Cancer, Ovarian Chemotherapy Ef... Calorie Deficie... Fasting, Interm...	Fasting Mimicki... Chemotherapy	35 Years - 70 Years	L-Nutra Inc

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