Epithelial Ovarian CancerNCT06386887
Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer
A study testing Intermittent Fasting and Neoadjuvant chemotherapy in people with Epithelial Ovarian Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Intermittent Fasting and Neoadjuvant chemotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Participants with stage III or IV EOC following primary debulking surgery
- Participants with recurrent epithelial ovarian cancer who will receive platinum-based chemotherapy OR
Show all 9Show fewer
- Participants who had undergone neoadjuvant chemotherapy and interval debulking surgery who will be receiving adjuvant (postoperative) chemotherapy
- Any invasive ovarian cancer histology
- Normal cognitive function
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Mariam AlHilli, MD
About this study
Official title: The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Intermittent Fasting, Neoadjuvant chemotherapy
- Keywords
- Short term fasting, Intermittent fasting, Intermittent energy restriction (IER), Fasting mimicking diet (FMD)
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingBehavioural
Also called Time restricted eating
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).
Neoadjuvant chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | Participants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy. Receives: Behavioral: Intermittent Fasting; Drug: Neoadjuvant chemotherapy |
| Standard of Care | Active comparator | 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. Receives: Drug: Neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks post intervention
Pre body composition
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
Measured: Baseline
Post body composition
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
Measured: Up to 12 weeks post intervention
Secondary outcomes (19)
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]).
Measured: 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]).
Measured: 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]).
Measured: 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]),
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start11 Jul 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, randomized, controlled study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Kuznicki, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386887
- Sponsor's protocol ID
- CASE1824
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06386887
- Acronym / sponsor ID
- CASE1824
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Short term fasting, Intermittent fasting, Intermittent energy restriction (IER), Fasting mimicking diet (FMD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, randomized, controlled study.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Behavioral: Intermittent Fasting, Drug: Neoadjuvant chemotherapyParticipants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy. |
| Standard of Care | Active comparator | Drug: Neoadjuvant chemotherapyParticipants will receive standard of care dietary recommendations and will provide a 3-day diet diary at study enrollment and during cycles 2 and 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Any invasive ovarian cancer histology
- Normal cognitive function
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingAlso: Time restricted eatingIntermittent 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). | Behavioural | Intermittent Fasting |
| Neoadjuvant chemotherapyChemotherapy 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. | Drug | Intermittent Fasting, Standard of Care |
Primary outcome
Intermittent fasting compliance as measured by serum glucose laboratory testing
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
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
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
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
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
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
Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
Intermittent fasting compliance as measured by serum glucose laboratory testing
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
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
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
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.
Intermittent fasting compliance as measured by IGF-1 laboratory testing
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
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
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
Intermittent fasting compliance as measured by serum glucose laboratory testing
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
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
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
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
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
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
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
Intermittent fasting compliance as measured by self-reported assessment
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
Intermittent fasting compliance as measured by self-reported assessment
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
Intermittent fasting compliance as measured by food diary
Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Intermittent fasting compliance as measured by food diary
Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Intermittent fasting compliance as measured by food diary
Time frame: Up to 12 weeks post intervention
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Pre body composition
Time frame: Baseline
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
Post body composition
Time frame: Up to 12 weeks post intervention
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
19 secondary outcomes
Chemotherapy related toxicity at Cycle 2
Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
Chemotherapy related toxicity at Cycle 3
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
Chemotherapy related toxicity at Cycle 4
Time frame: Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days)
Chemotherapy related toxicity at post treatment
Time frame: Up to 12 weeks post intervention
ESAS Score at Enrollment
Time frame: At baseline
ESAS Score at Cycle 2
Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
ESAS Score at Cycle 3
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
ESAS Score at Post Treatment
Time frame: Up to 12 weeks post intervention
SF-125 Score at Baseline
Time frame: At baseline
SF-125 Score at Cycle 2
Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
SF-125 Score at Cycle 3
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
SF-125 Score at Post Treatment
Time frame: Up to 12 weeks post intervention
Pre Quality of Life (QLQ-C30) Score at Baseline
Time frame: At baseline
Post Quality of Life (QLQ-C30) Score Post Treatment
Time frame: Up to 12 weeks post intervention
Pre Functional Assessment (FACT-O) Score at Baseline
Time frame: Up to 12 weeks post intervention
Post Functional Assessment (FACT-O) Score Post Treatment
Time frame: Up to 12 weeks post intervention
AIM Survey Score at Cycle 2
Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
AIM Survey Score at Cycle 3
Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
AIM Survey Score at Post Treatment
Time frame: Up to 12 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Kuznicki, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting and Neoadjuvant chemotherapy in people with Epithelial Ovarian Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Kuznicki, MD ((216) 444-8811, kuznicm@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermittent fasting compliance as measured by serum glucose laboratory testing (time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.