NCT06386887 Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer
| NCT ID | NCT06386887 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Epithelial Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-07-11 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Michelle Kuznicki, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06386887 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Epithelial Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386887 currently recruiting?
Yes, NCT06386887 is actively recruiting participants. Contact the research team at kuznicm@ccf.org for enrollment information.
Where is the NCT06386887 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06386887 clinical trial?
NCT06386887 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Michelle Kuznicki, MD at The Cleveland Clinic. The trial plans to enroll 20 participants.
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