Fasting during chemotherapy for ovarian cancer
Official title: The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
Run by Case Comprehensive Cancer Center · NCT06386887 · Data updated 2026-11-12
This study is testing if intermittent fasting during chemotherapy can help improve quality of life and treatment results for people with ovarian cancer compared to regular eating habits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | July 11, 2024 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06386887 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a confirmed diagnosis of primary epithelial ovarian cancer who are scheduled to receive neoadjuvant chemotherapy.
✕Probably not a fit
Patients with severe malnutrition, type I diabetes on insulin, or those with malignant bowel obstruction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the feasibility and safety of intermittent fasting during neoadjuvant chemotherapy in patients with epithelial ovarian cancer. Participants will be assigned to either a fasting intervention or standard dietary recommendations for six weeks. The study aims to assess the impact of fasting on quality of life, symptoms, and treatment outcomes, while also exploring its effects on body composition, chemotherapy toxicity, and the gut microbiome. Researchers will compare the two groups to determine which approach is more effective and acceptable for patients.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life and treatment outcomes for patients undergoing chemotherapy for ovarian cancer.
How similar studies have gone: While the concept of dietary interventions during chemotherapy is being explored, this specific approach of intermittent fasting during neoadjuvant chemotherapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and above * Participants with confirmed diagnosis of primary epithelial ovarian cancer (EOC) by internal cytologic or histologic evaluation (including fallopian tube and primary peritoneal cancer) * Participants receiving platinum-based chemotherapy for ovarian cancer including * Participants with stage III or IV EOC planned to undergo neoadjuvant chemotherapy (including participants who had a diagnostic laparoscopy or aborted debulking) OR * Participants with stage III or IV EOC following primary debulking surgery * Participants with recurrent epithelial ovarian cancer who will receive platinum-based chemotherapy OR * Participants who had undergone neoadjuvant chemotherapy and interval debulking surgery who will be receiving adjuvant (postoperative) chemotherapy * Any invasive ovarian cancer histology * Normal cognitive function Exclusion Criteria: * Age \<18 years * Malignant complete or partial bowel obstruction confirmed on imaging. * Participants unable to provide informed consent. * BMI \<18 * Participants diagnosed with severe malnutrition as assessed by study dietitian * Type I diabetes on insulin * Absence of pretreatment CT abdomen and pelvis imaging or \>4-6 weeks between imaging and cycle 1 of chemotherapy.
Where it's running
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Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Michelle Kuznicki, MD — The Cleveland Clinic
- Study coordinator: Michelle Kuznicki, MD
- Email: kuznicm@ccf.org
- Phone: (216) 444-8811
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.