Calorie Deficiency, Cancer, Ovarian, Chemotherapy Effect, Fasting, Intermittent
Conditions
Keywords
Fasting mimicking diet, Gynecologic malignancy, Chemotherapy
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.
Interventions
Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.
DRUGChemotherapy
6 cycles of standard chemotherapy for the gynecologic malignancy.
Sponsors
University of Tennessee Medical Center
L-Nutra Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Outcomes Assessor
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire | 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. |
| Rate of Adherence | Week 0-21 | The ability to adhere to a 5-day fasting mimicking diet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Week 0, Week12, Week 21 | Change in body weight. |
| Change in Body Composition | Week 0, Week12, Week 21 | Changes in weight, skeletal muscle mass, body fat percentage by the Inbody(R) Body Composition Analyzer. |
| Change in HbA1c | Week 0, Week 21 | Change in blood HbA1c. |
| Change in Insulin Like Growth Factor 1 (IGF-1) Concentration | Week 0, Week 21 | Change in blood insulin like growth factor 1 level. |
| Change in High-sensitivity C reactive protein Concentration | Week 0, Week 21 | Change in blood C reactive protein level. |
| Change in Fasting Glucose Concentration | Week 0, Week 21 | Change in fasting glucose level. |
| Change in planned chemotherapy regimen | Week 0-21 | Deviation from the planned chemotherapy regimen. |
| Number of Hospitalization Days | Week 0-21 | Days of hospitalization |
| Rate of Chemotherapy Side Effects | Week 0-21 | Rate of Adverse effects associated with chemotherapy |
| Change in Fasting Insulin Concentration | Week 0, Week 21 | Change in fasting insulin level. |
| Change in Leptin Concentration | Week 0, Week 21 | Change in blood leptin level. |
Countries
United States
Contacts
Primary ContactMin Wei, PhD
Backup ContactJonathan D Boone, MD
Outcome results
None listed