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.
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
Age <18 years
Malignant complete or partial bowel obstruction confirmed on imaging.
Participants unable to provide informed consent.
BMI <18
Parallel
Intermittent Fasting
BehavioralIntermittent 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).
Neoadjuvant chemotherapy
DrugChemotherapy 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.
Intermittent fasting compliance as measured by serum glucose laboratory testing
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.
Intermittent fasting compliance as measured by ketone laboratory testing
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.
Intermittent fasting compliance as measured by IGF-1 laboratory testing
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.
Intermittent fasting compliance as measured by insulin laboratory testing
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
Chemotherapy related toxicity at Cycle 2
Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]).
Chemotherapy related toxicity at Cycle 3
Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]).
Chemotherapy related toxicity at Cycle 4
Participants that undergo an additional cycle of chemotherapy will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]).
Chemotherapy related toxicity at post treatment
Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]),
Click on the lead sponsor to view all of their trials.
