protocolSection identificationModule nctId: NCT06386887, orgStudyIdInfo id: CASE1824, briefTitle: Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Epithelial Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two arm, randomized, controlled study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Participants' cross-sectional skeletal muscle areas will be measured. Measurements will be performed on CT scans obtained within 4-6 weeks of treatment initiation (with a 7-day screening window) by a fellowship-trained, experienced radiologist and imaging specialist in consensus who will be blinded to participant clinical variables and treatment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Fasting, interventions name: Neoadjuvant chemotherapy, outcomesModule primaryOutcomes measure: Intermittent fasting compliance as measured by serum glucose laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by ketone laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by insulin laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by serum glucose laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by ketone laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by insulin laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by serum glucose laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by ketone laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by insulin laboratory testing, primaryOutcomes measure: Intermittent fasting compliance as measured by self-reported assessment, primaryOutcomes measure: Intermittent fasting compliance as measured by self-reported assessment, primaryOutcomes measure: Intermittent fasting compliance as measured by food diary, primaryOutcomes measure: Intermittent fasting compliance as measured by food diary, primaryOutcomes measure: Intermittent fasting compliance as measured by food diary, primaryOutcomes measure: Pre body composition, primaryOutcomes measure: Post body composition, secondaryOutcomes measure: Chemotherapy related toxicity at Cycle 2, secondaryOutcomes measure: Chemotherapy related toxicity at Cycle 3, secondaryOutcomes measure: Chemotherapy related toxicity at Cycle 4, secondaryOutcomes measure: Chemotherapy related toxicity at post treatment, secondaryOutcomes measure: ESAS Score at Enrollment, secondaryOutcomes measure: ESAS Score at Cycle 2, secondaryOutcomes measure: ESAS Score at Cycle 3, secondaryOutcomes measure: ESAS Score at Post Treatment, secondaryOutcomes measure: SF-125 Score at Baseline, secondaryOutcomes measure: SF-125 Score at Cycle 2, secondaryOutcomes measure: SF-125 Score at Cycle 3, secondaryOutcomes measure: SF-125 Score at Post Treatment, secondaryOutcomes measure: Pre Quality of Life (QLQ-C30) Score at Baseline, secondaryOutcomes measure: Post Quality of Life (QLQ-C30) Score Post Treatment, secondaryOutcomes measure: Pre Functional Assessment (FACT-O) Score at Baseline, secondaryOutcomes measure: Post Functional Assessment (FACT-O) Score Post Treatment, secondaryOutcomes measure: AIM Survey Score at Cycle 2, secondaryOutcomes measure: AIM Survey Score at Cycle 3, secondaryOutcomes measure: AIM Survey Score at Post Treatment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False