Fasting During Chemotherapy for Ovarian Cancer
This study is looking at whether intermittent fasting (periods of time you don't eat) is possible and safe for women with epithelial ovarian cancer (a common type of ovarian cancer) who are receiving neoadjuvant chemotherapy (chemotherapy given before surgery). Researchers want to see if this type of fasting can improve quality of life, symptoms, and overall results. You could be eligible if you are 18 or older, have a confirmed diagnosis of epithelial ovarian cancer, and are receiving platinum-based chemotherapy. The study will measure how well participants follow the fasting plan by checking blood sugar (glucose), ketone, and IGF-1 levels. The goal is to see if intermittent fasting is practical, safe, and acceptable during chemotherapy.
- Study design
- This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will receive standard chemotherapy every 3 weeks for 3 to 4 cycles. The intermittent fasting involves 16 hours of fasting and 8 hours of eating for 5 days, followed by 2 days of regular eating.
- Compensation
- Not stated in the trial record.
- Follow-up
- Compliance with intermittent fasting will be measured at Day 1 of each 21-day chemotherapy cycle.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer
At a glance
Conditions
NCT06386887
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center
Cleveland, Ohiono site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Michelle Kuznicki, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
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Inclusion
Exclusion
What this trial measures
- Intermittent fasting compliance as measured by serum glucose laboratory testingDay 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.
- Intermittent fasting compliance as measured by ketone laboratory testingDay 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.
- Intermittent fasting compliance as measured by IGF-1 laboratory testingDay 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.
- Intermittent fasting compliance as measured by insulin laboratory testingDay 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
- Intermittent fasting compliance as measured by serum glucose laboratory testingWeek 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.
- Intermittent fasting compliance as measured by ketone laboratory testingWeek 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy. which will be measured by metabolic laboratory tests (serum glucose, ketone, IGF-1, and insulin) prior to each chemotherapy.
- Intermittent fasting compliance as measured by IGF-1 laboratory testingWeek 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.
- Intermittent fasting compliance as measured by insulin laboratory testingWeek 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
- Intermittent fasting compliance as measured by serum glucose laboratory testingWeek 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.
- Intermittent fasting compliance as measured by ketone laboratory testingWeek 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.
- Intermittent fasting compliance as measured by IGF-1 laboratory testingWeek 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.
- Intermittent fasting compliance as measured by insulin laboratory testingWeek 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
- Intermittent fasting compliance as measured by self-reported assessmentWeek 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
- Intermittent fasting compliance as measured by self-reported assessmentWeek 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
- Intermittent fasting compliance as measured by food diaryWeek 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
- Intermittent fasting compliance as measured by food diaryWeek 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
- Intermittent fasting compliance as measured by food diaryUp to 12 weeks post intervention
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
- Pre body compositionBaseline
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
- Post body compositionUp to 12 weeks post intervention
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.