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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
20
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).
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.
Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGIntermittent 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.
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
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.
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
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.
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
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.
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
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.
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
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. which will be measured by metabolic laboratory tests (serum glucose, ketone, IGF-1, and insulin) prior to each chemotherapy.
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
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.
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
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.
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
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.
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
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.
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
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.
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
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.
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by self-reported assessment
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by self-reported assessment
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by food diary
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by food diary
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Intermittent fasting compliance as measured by food diary
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Time frame: Up to 12 weeks post intervention
Pre body composition
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
Time frame: Baseline
Post body composition
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
Time frame: Up to 12 weeks post intervention
Chemotherapy related toxicity at Cycle 2
Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]).
Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
Chemotherapy related toxicity at Cycle 3
Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]).
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
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 \[CTCAE version 5.0\]).
Time frame: Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days)
Chemotherapy related toxicity at post treatment
Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]),
Time frame: Up to 12 weeks post intervention
ESAS Score at Enrollment
Participants will complete Edmonton Symptom Assessment Questionnaires (ESAS) at enrollment. The ESAS assesses pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
Time frame: At baseline
ESAS Score at Cycle 2
Participants will complete Edmonton Symptom Assessment Questionnaires (ESAS). The ESAS assesses pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
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Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
ESAS Score at Cycle 3
Participants will complete Edmonton Symptom Assessment Questionnaires (ESAS). The ESAS assesses pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
ESAS Score at Post Treatment
Participants will complete Edmonton Symptom Assessment Questionnaires (ESAS). The ESAS assesses pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
Time frame: Up to 12 weeks post intervention
SF-125 Score at Baseline
Participants will complete Study Short Form-12 Health Survey (SF-125) at enrollment. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
Time frame: At baseline
SF-125 Score at Cycle 2
Participants will complete Study Short Form-12 Health Survey (SF-125) day 1 cycle 2. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
SF-125 Score at Cycle 3
Participants will complete Study Short Form-12 Health Survey (SF-125) day 1 cycle 3. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
SF-125 Score at Post Treatment
Participants will complete Study Short Form-12 Health Survey (SF-125) post treatment. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.
Time frame: Up to 12 weeks post intervention
Pre Quality of Life (QLQ-C30) Score at Baseline
Quality of life questionnaires will be distributed at enrollment and will be compared between IF and control groups. Quality of life will be measured by Quality of life will be measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). EORTC QLQ-C30 is a 30 item questionnaire. Higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time frame: At baseline
Post Quality of Life (QLQ-C30) Score Post Treatment
Quality of life questionnaires will be distributed at enrollment and will be compared between IF and control groups. Quality of life will be measured by Quality of life will be measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). EORTC QLQ-C30 is a 30 item questionnaire. Higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time frame: Up to 12 weeks post intervention
Pre Functional Assessment (FACT-O) Score at Baseline
Functional Assessment of Cancer Therapy- Ovarian (FACT-O) will be administered post treatment and will be compared between IF and control groups. FACT-O is a 39 item questionnaire with a 5 point Likert-type scale. Scores range from 0-156. The higher the score, the better the quality of life.
Time frame: Up to 12 weeks post intervention
Post Functional Assessment (FACT-O) Score Post Treatment
Functional Assessment of Cancer Therapy- Ovarian (FACT-O) will be administered at enrollment and will be compared between IF and control groups. FACT-O is a 39 item questionnaire with a 5 point Likert-type scale. Scores range from 0-156. The higher the score, the better the quality of life.
Time frame: Up to 12 weeks post intervention
AIM Survey Score at Cycle 2
Acceptability of intervention Measure (AIM) questionnaire will be administered IF participants. AIM has 4 item psychometric assessment times measuring acceptability of intervention. Scale values range from 1 to 5. Overall scores that are lower indicating lower acceptability, and higher scores indicating greater acceptability, appropriateness, and feasibility.
Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
AIM Survey Score at Cycle 3
Acceptability of intervention Measure (AIM) questionnaire will be administered IF participants. AIM has 4 item psychometric assessment times measuring acceptability of intervention. Scale values range from 1 to 5. Overall scores that are lower indicating lower acceptability, and higher scores indicating greater acceptability, appropriateness, and feasibility.
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
AIM Survey Score at Post Treatment
Acceptability of intervention Measure (AIM) questionnaire will be administered IF participants. AIM has 4 item psychometric assessment times measuring acceptability of intervention. Scale values range from 1 to 5. Overall scores that are lower indicating lower acceptability, and higher scores indicating greater acceptability, appropriateness, and feasibility.
Time frame: Up to 12 weeks post intervention