Clinical trial
The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
Name
CASE1824
Description
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.
Trial arms
Trial start
2024-05-30
Estimated PCD
2025-12-01
Trial end
2026-01-01
Status
Not yet recruiting
Treatment
Intermittent Fasting
Intermittent fasting (IF) also known as time restricted eating regimen consisting of 16 hours of fasting and 8 hours of ad libitum feeding for 5 days followed by ad libitum feeding for 2 days has been proposed. With this type of intervention, there are no dietary restrictions to the type or quality of food and it decreased daily energy intake by 20%. Participants will be asked to follow an IF schedule consisting of 16 hour of continuous fasting per day for 5 days a week. This will be started 2 days prior to chemotherapy (cycle 2).
Arms:
Intermittent Fasting
Other names:
Time restricted eating
Neoadjuvant chemotherapy
Chemotherapy will be given as standard treatment every 3 weeks (21 days) and continue for 3 to 4 cycles per routine care. As chemotherapy is not part of this research study, participants will begin standard chemotherapy as decided by their physician.
Arms:
Intermittent Fasting, Standard of Care
Size
20
Primary endpoint
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)
Intermittent fasting compliance as measured by insulin laboratory testing
Day 1 of cycle 1 (each cycle consisting of 21 days)
Intermittent fasting compliance as measured by serum glucose laboratory testing
Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by ketone laboratory testing
Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by IGF-1 laboratory testing
Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by insulin laboratory testing
Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by serum glucose laboratory testing
Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by ketone laboratory testing
Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by IGF-1 laboratory testing
Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by insulin laboratory testing
Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by self-reported assessment
Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by self-reported assessment
Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by food diary
Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by food diary
Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by food diary
Up to 12 weeks post intervention
Pre body composition
Baseline
Post body composition
Up to 12 weeks post intervention
Eligibility criteria
Inclusion Criteria:
* Age 18 years and above
* Participants with confirmed diagnosis of epithelial ovarian cancer (EOC) by internal cytologic or histologic evaluation (including fallopian tube and primary peritoneal cancer)
* Participant who had undergone laparoscopic evaluation or laparotomy for diagnosis but did not proceed with surgical debulking
* Participants with stage III or IV EOC planned to undergo NACT or already receiving NACT (cycle 1)
* 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.
Protocol
{'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'}}
Updated at
2024-05-17
1 organization
1 drug
1 indication
Organization
Case Comprehensive Cancer CenterDrug
CisplatinIndication
Ovarian Cancer