RecruitingNot ApplicableNCT06376604

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

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


Sponsor

L-Nutra Inc

Enrollment

30 participants

Start Date

Sep 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 35 YearsMax Age: 70 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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.

Interventions

OTHERFasting 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.

DRUGChemotherapy

6 cycles of standard chemotherapy for the gynecologic malignancy.


Locations(1)

The University of Tennessee Medical Center

Knoxville, Tennessee, United States

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NCT06376604


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