Fasting during chemotherapy for ovarian cancer
The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06386887 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe malnutrition, type I diabetes on insulin, or those with malignant bowel obstruction may not benefit from this study.
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 performed: While the concept of dietary interventions during chemotherapy is being explored, this specific approach of intermittent fasting during neoadjuvant chemotherapy is relatively novel.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- 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
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.