Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Not Applicable

Recruiting

• Conditions: Cancer, Ovarian; Chemotherapy Effect; Calorie Deficiency; Fasting, Intermittent
• Interventions: Other: Fasting Mimicking Diet; Drug: Chemotherapy

• Registration Number: NCT06376604
• Lead Sponsor: L-Nutra Inc

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.

Study Timeline

• Study Start: 2021-09-08
• Status Verified: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMD	Chemotherapy	In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
Control	Chemotherapy	Subjects will receive the standard care and no dietary changes.
FMD	Fasting Mimicking Diet	In addition to the standard care, subject will consume a 5-day fasting mimicking diet.

Primary Outcome Measures

Name	Time	Method
Rate of Adherence	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	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 Outcome Measures

Name	Time	Method
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 Fasting Insulin Concentration	Week 0, Week 21	Change in fasting insulin level.
Change in Fasting Glucose Concentration	Week 0, Week 21	Change in fasting glucose level.
Change in High-sensitivity C reactive protein Concentration	Week 0, Week 21	Change in blood C reactive protein level.
Change in Leptin Concentration	Week 0, Week 21	Change in blood leptin 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

Trial Locations

Locations (1)

The University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States