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Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

RECRUITINGN/ASponsored by L-Nutra Inc
Actively Recruiting
PhaseN/A
SponsorL-Nutra Inc
Started2021-09-08
Est. completion2025-09-01
Eligibility
Age35 Years – 70 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 35 Years – 70 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions5

Calorie DeficiencyCancerCancer, OvarianChemotherapy EffectFasting, Intermittent

Locations1 site

The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Jonathan D Boone, MD865-305-5622jboone@utmck.edu

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