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Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Recruiting
35-70 years
Female
Phase N/A

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Overview

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

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.

Eligibility

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.

Study details
    Cancer
    Ovarian
    Chemotherapy Effect
    Calorie Deficiency
    Fasting
    Intermittent

NCT06376604

L-Nutra Inc

2 May 2024

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