Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
Overview
- Phase
- Not Applicable
- Intervention
- Fasting Mimicking Diet
- Conditions
- Cancer, Ovarian
- Sponsor
- L-Nutra Inc
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of Adherence
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Arms & Interventions
FMD
In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
Intervention: Fasting Mimicking Diet
FMD
In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
Intervention: Chemotherapy
Control
Subjects will receive the standard care and no dietary changes.
Intervention: Chemotherapy
Outcomes
Primary Outcomes
Rate of Adherence
Time Frame: Week 0-21
The ability to adhere to a 5-day fasting mimicking diet.
Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
Time Frame: Week 0-21
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.
Secondary Outcomes
- Change in Body Weight(Week 0, Week12, Week 21)
- Change in Body Composition(Week 0, Week12, Week 21)
- Change in HbA1c(Week 0, Week 21)
- Change in Insulin Like Growth Factor 1 (IGF-1) Concentration(Week 0, Week 21)
- Change in Fasting Insulin Concentration(Week 0, Week 21)
- Change in Fasting Glucose Concentration(Week 0, Week 21)
- Change in High-sensitivity C reactive protein Concentration(Week 0, Week 21)
- Change in Leptin Concentration(Week 0, Week 21)
- Change in planned chemotherapy regimen(Week 0-21)
- Number of Hospitalization Days(Week 0-21)
- Rate of Chemotherapy Side Effects(Week 0-21)