This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.
6 cycles of standard chemotherapy for the gynecologic malignancy.
The University of Tennessee Medical Center
Knoxville, Tennessee, United States
RECRUITINGQuality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
The NFOSI-18 questionnaire allows for a uniform assessment of health-related quality of life through an 18-question (5-point Likert-type scale) survey including four subscale domains: Disease-Related Symptoms - Physical, Disease-Related Symptoms - Emotional, Treatment Side Effects. and Function/Well-Being. To calculate subscale scores, sum the item scores within each domain. Higher subscale scores indicate more significant symptom burden or impact. The total score is obtained by summing all 18 item scores. A higher total score reflects more severe symptoms overall.
Time frame: Week 0-21
Rate of Adherence
The ability to adhere to a 5-day fasting mimicking diet.
Time frame: Week 0-21
Change in Body Weight
Change in body weight.
Time frame: Week 0, Week12, Week 21
Change in Body Composition
Changes in weight, skeletal muscle mass, body fat percentage by the Inbody(R) Body Composition Analyzer.
Time frame: Week 0, Week12, Week 21
Change in HbA1c
Change in blood HbA1c.
Time frame: Week 0, Week 21
Change in Insulin Like Growth Factor 1 (IGF-1) Concentration
Change in blood insulin like growth factor 1 level.
Time frame: Week 0, Week 21
Change in Fasting Insulin Concentration
Change in fasting insulin level.
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Time frame: Week 0, Week 21
Change in Fasting Glucose Concentration
Change in fasting glucose level.
Time frame: Week 0, Week 21
Change in High-sensitivity C reactive protein Concentration
Change in blood C reactive protein level.
Time frame: Week 0, Week 21
Change in Leptin Concentration
Change in blood leptin level.
Time frame: Week 0, Week 21
Change in planned chemotherapy regimen
Deviation from the planned chemotherapy regimen.
Time frame: Week 0-21
Number of Hospitalization Days
Days of hospitalization
Time frame: Week 0-21
Rate of Chemotherapy Side Effects
Rate of Adverse effects associated with chemotherapy
Time frame: Week 0-21