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Trial Title:
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
NCT ID:
NCT06376604
Condition:
Cancer, Ovarian
Chemotherapy Effect
Calorie Deficiency
Fasting, Intermittent
Conditions: Official terms:
Neoplasms
Ovarian Neoplasms
Conditions: Keywords:
Fasting mimicking diet
Gynecologic malignancy
Chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
Outcomes Assessor
Intervention:
Intervention type:
Other
Intervention name:
Fasting Mimicking Diet
Description:
Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day
of, and 1 day following chemotherapy treatments.
Arm group label:
FMD
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
6 cycles of standard chemotherapy for the gynecologic malignancy.
Arm group label:
Control
Arm group label:
FMD
Summary:
This study evaluates how lifestyle modifications that may be made to manage chemotherapy
side effects in patients with gynecologic malignancies.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
The study focuses on the chemotherapy of gynecologic malignancies.
Minimum age:
35 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan D Boone, MD
Phone:
865-305-5622
Email:
jboone@utmck.edu
Start date:
September 8, 2021
Completion date:
December 30, 2025
Lead sponsor:
Agency:
L-Nutra Inc
Agency class:
Industry
Collaborator:
Agency:
University of Tennessee Medical Center
Agency class:
Other
Source:
L-Nutra Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06376604
