RecruitingNot ApplicableNCT06386887

Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer


Sponsor

Case Comprehensive Cancer Center

Enrollment

20 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are: * Is it feasible to use intermittent fasting during neoadjuvant chemotherapy? * Is it safe to use intermittent fasting during neoadjuvant chemotherapy? * Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy? Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes. Participants will: * Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy. * All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing. * Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether fasting (not eating) for a short period around chemotherapy sessions helps improve treatment outcomes for women with ovarian cancer. Fasting may help protect healthy cells from chemotherapy side effects while making cancer cells more vulnerable. **You may be eligible if...** - You are 18 or older - You have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer - You are scheduled to receive platinum-based chemotherapy (before or after surgery, or for recurrent cancer) - You have normal cognitive function **You may NOT be eligible if...** - You have a complete or partial bowel blockage - Your BMI is below 18 (underweight) - You have been assessed as severely malnourished - You have Type 1 diabetes requiring insulin - You do not have recent CT imaging of your abdomen and pelvis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntermittent Fasting

Intermittent fasting (IF) also known as time restricted eating regimen consisting of 16 hours of fasting and 8 hours of ad libitum feeding for 5 days followed by ad libitum feeding for 2 days has been proposed. With this type of intervention, there are no dietary restrictions to the type or quality of food and it decreased daily energy intake by 20%. Participants will be asked to follow an IF schedule consisting of 16 hour of continuous fasting per day for 5 days a week. This will be started 2 days prior to chemotherapy (cycle 2).

DRUGNeoadjuvant chemotherapy

Chemotherapy will be given as standard treatment every 3 weeks (21 days) and continue for 3 to 4 cycles per routine care. As chemotherapy is not part of this research study, participants will begin standard chemotherapy as decided by their physician.


Locations(1)

Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT06386887


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