Clinical trial NCT06376604: Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
Official title: Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Ovarian
Chemotherapy Effect
Calorie Deficiency
Fasting, Intermittent
Keywords: Fasting mimicking diet
Gynecologic malignancy
Chemotherapy
Lead sponsor: L-Nutra Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Tennessee Medical Center
First posted: 2024-04-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
timeFrame: Week 0-21
measure: Rate of Adherence
timeFrame: Week 0-21
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Week 0, Week12, Week 21
measure: Change in Body Composition
timeFrame: Week 0, Week12, Week 21
measure: Change in HbA1c
timeFrame: Week 0, Week 21
measure: Change in Insulin Like Growth Factor 1 (IGF-1) Concentration
timeFrame: Week 0, Week 21
measure: Change in Fasting Insulin Concentration
timeFrame: Week 0, Week 21
measure: Change in Fasting Glucose Concentration
timeFrame: Week 0, Week 21
measure: Change in High-sensitivity C reactive protein Concentration
timeFrame: Week 0, Week 21
measure: Change in Leptin Concentration
timeFrame: Week 0, Week 21
measure: Change in planned chemotherapy regimen
timeFrame: Week 0-21
measure: Number of Hospitalization Days
timeFrame: Week 0-21
measure: Rate of Chemotherapy Side Effects
timeFrame: Week 0-21
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: The University of Tennessee Medical Center
name: Jonathan D Boone
role: PRINCIPAL_INVESTIGATOR
References:
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