An interventional study of Intermittent Fasting and Neoadjuvant chemotherapy in Epithelial Ovarian Cancer, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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:
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:
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:
797 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 101 are open to participants now.
This study's planned enrollment of 20 is below the median of 45 across 584 interventional studies indexed under Carcinoma, Ovarian Epithelial.
Browse Carcinoma, Ovarian Epithelial studies →Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants receiving platinum-based chemotherapy for ovarian cancer including
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy.
Behavioral: Intermittent Fasting · Drug: Neoadjuvant chemotherapy
Participants will receive standard of care dietary recommendations and will provide a 3-day diet diary at study enrollment and during cycles 2 and 3.
Drug: Neoadjuvant chemotherapy
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).
Also known as: Time restricted eating
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.
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: 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.
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
Plan to share: Yes — All collected participant data will be shared through publication including clinical data, laboratory results, CT data, qualitative data (questionnaire's) in additional, molecular data, histologic data, treatment response after statistical analysis. All data will be shared without participant identifiers.
Time frame: Anticipated 6-2025 - indefinitely through publication of data
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Nov 2026, 28 months after the start.
Of 30 interventional studies with no phase under Carcinoma, Ovarian Epithelial, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 93. This study's planned 28 months is below that.
How these figures are worked out, and which studies are left out of them.
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