Using a fasting mimicking diet to manage chemotherapy side effects in women with gynecologic cancers
Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
NA · L-Nutra Inc · NCT06376604
This study is testing if a special diet that mimics fasting can help women with gynecologic cancers feel better and manage side effects while undergoing chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | Female |
| Sponsor | L-Nutra Inc (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT06376604 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a fasting mimicking diet (FMD) on chemotherapy-related side effects in women undergoing treatment for gynecologic malignancies. Participants will be assigned to either a control group with no dietary restrictions or a treatment group following a 5-day FMD before, during, and after chemotherapy sessions. The study aims to assess the feasibility of the FMD, its metabolic effects, and its influence on patient-reported side effects and quality of life. By exploring non-pharmacological approaches, the research seeks to provide insights into improving the overall treatment experience for these patients.
Who should consider this trial
Good fit: Ideal candidates are women aged 35-70 with biopsy-proven gynecologic malignancies who are scheduled to undergo chemotherapy.
Not a fit: Patients who are pregnant, nursing, or have significant medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chemotherapy-related side effects and enhance the quality of life for patients.
How similar studies have performed: While the fasting mimicking diet is a novel approach in this context, previous studies have shown promise in using dietary modifications to manage chemotherapy side effects.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Knoxville, Tennessee
- The University of Tennessee Medical Center — Knoxville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Jonathan D Boone — The University of Tennessee Medical Center
- Study coordinator: Min Wei, PhD
- Email: mwei@l-nutra.com
- Phone: 323.791.2426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Ovarian, Chemotherapy Effect, Calorie Deficiency, Fasting, Intermittent, Fasting mimicking diet, Gynecologic malignancy, Chemotherapy