RecruitingRecruiting
Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer
NCT06386887 · Case Comprehensive Cancer Center
In plain English
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Official title
The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
About this study
The quality of diet can affect the biology of cancer. For example, evidence implies a high fat/ Western diet may impose adverse events on ovarian cancer outcomes, and the potential that the gut microbiome alterations secondary to dietary changes may impact tumor responsiveness to treatment and outcomes. This study seeks to clarify the effect of dietary intervention on the tumor and gut microbiome and ovarian cancer biology. The objectives of this study include:
* Primary: To test the feasibility and safety of IF during neoadjuvant chemotherapy (including effects on body composition)
* Secondary: To measure the effects of IF on participant reported outcomes, chemotherapy toxicity and quality of life.
* Exploratory: To test the effect of IF on pathologic response, systemic inflammatory and immune responses, microbial diversity and metabolic pathway alterations.
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.
Study design
Enrollment target: 20 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-07-11
Estimated completion: 2026-07-01
Last updated: 2026-05-07
Interventions
Behavioral: Intermittent FastingDrug: Neoadjuvant chemotherapy
Primary outcomes
- • Intermittent fasting compliance as measured by serum glucose laboratory testing (Day 1 of cycle 1 (each cycle consisting of 21 days))
- • Intermittent fasting compliance as measured by ketone laboratory testing (Day 1 of cycle 1 (each cycle consisting of 21 days))
- • Intermittent fasting compliance as measured by IGF-1 laboratory testing (Day 1 of cycle 1 (each cycle consisting of 21 days))
Sponsor
Case Comprehensive Cancer Center · other
Contacts & investigators
ContactMichelle Kuznicki, MD · contact · kuznicm@ccf.org · (216) 444-8811
ContactJackie Ludwig · contact · ludwigj@ccf.org · 216 390-2492
InvestigatorMichelle Kuznicki, MD · principal_investigator, The Cleveland Clinic
All locations (1)
Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer CenterRecruiting
Cleveland, Ohio, United States