RECRUITINGINTERVENTIONAL
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
About This Trial
This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
Fasting 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.
DRUG
Chemotherapy
6 cycles of standard chemotherapy for the gynecologic malignancy.
Locations (1)
The University of Tennessee Medical Center
Knoxville, Tennessee, United States