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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days) |
| Intermittent fasting compliance as measured by ketone laboratory testing |
| Measure | Description | Time Frame |
|---|---|---|
| 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]). | Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days) |
| Chemotherapy related toxicity at Cycle 3 |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Kuznicki, MD | Contact | (216) 444-8811 | kuznicm@ccf.org | |
| Jackie Ludwig | Contact | 216 390-2492 | ludwigj@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Kuznicki, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center | Recruiting | Cleveland | Ohio | 44195 | United States |
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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Anticipated 6-2025 - indefinitely through publication of data
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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Two arm, randomized, controlled study.
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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.
|
|
| Neoadjuvant chemotherapy | Drug | 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. |
|
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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 weeks post intervention |
| Pre body composition | Pre- and post- treatment body composition will be assessed by Computed Tomography scans. | Baseline |
| Post body composition | Pre- and post- treatment body composition will be assessed by Computed Tomography scans. | Up to 12 weeks post intervention |
Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE version 5.0]). |
| 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]). | 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]), | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 weeks post intervention |
|
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |