Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

NCT06386887 | Recruiting DMC

• 1 other identifier: CASE1824
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer

Keywords

Short term fasting; Intermittent fasting; Intermittent energy restriction (IER); Fasting mimicking diet (FMD)

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (19)

• Chemotherapy related toxicity at Cycle 2

  Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)

• Chemotherapy related toxicity at Cycle 3

  Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)

• Chemotherapy related toxicity at Cycle 4

  Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days)

• Chemotherapy related toxicity at post treatment

  Up to 12 weeks post intervention

• ESAS Score at Enrollment

  At baseline

Study Arms (2)

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.

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.

Drug: Neoadjuvant chemotherapy

Interventions

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).

Also known as: Time restricted eating

Intermittent Fasting

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.

Intermittent Fasting; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Intermittent Fasting

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Michelle Kuznicki, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Kuznicki, MD

CONTACT

(216) 444-8811; kuznicm@ccf.org

Jackie Ludwig

CONTACT

216 390-2492; ludwigj@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm, randomized, controlled study.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 26, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Anticipated 6-2025 - indefinitely through publication of data

Locations

US (1)