Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

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?

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.

Study Overview

• Status: Recruiting
• Conditions: Epithelial Ovarian Cancer
• Intervention / Treatment: Behavioral: Intermittent Fasting; Drug: Neoadjuvant chemotherapy

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jackie Ludwig; Phone Number: 216 390-2492; Email: ludwigj@ccf.org
• Study Contact Backup: Name: Michelle Kuznicki, MD; Phone Number: (216) 444-8811; Email: kuznicm@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center
      • Contact: Mariam AlHilli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

  • 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
  • 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent Fasting; 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; 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).; Other Names: Time restricted eating; Drug: Neoadjuvant chemotherapy; 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.
Active Comparator: Standard of Care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Michelle Kuznicki, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Intermittent fasting; Short term fasting; Intermittent energy restriction (IER); Fasting mimicking diet (FMD)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Ovarian Neoplasms; Behavior; Feeding Behavior; Fasting; Carcinoma, Ovarian Epithelial; Intermittent Fasting; Therapeutics; Combined Modality Therapy; Neoadjuvant Therapy
• Other Study ID Numbers: CASE1824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Anticipated 6-2025 - indefinitely through publication of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No