Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

NCT ID: NCT06386887

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2026-01-01

Brief 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 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.

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intermittent Fasting

Participants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy.

Group Type: EXPERIMENTAL

Intermittent Fasting

Intervention Type: 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).

Neoadjuvant chemotherapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Neoadjuvant chemotherapy

Intervention Type: 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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

Time restricted eating

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariam AlHilli, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mariam AlHilli, MD

Role: CONTACT

ALHILLM@ccf.org

(216) 445-8090

Jackie Ludwig

Role: CONTACT

ludwigj@ccf.org

216 390-2492

Facility Contacts

Mariam AlHilli, MD

Role: primary

Other Identifiers

CASE1824

Identifier Type: -

Identifier Source: org_study_id