Recruiting

Timed Fasting

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06386887

Conditions

Epithelial Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intermittent Fasting

Neoadjuvant chemotherapy

Study Details

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

Study ID

NCT06386887

Start date

Jul 11, 2024

Status verified date

Aug, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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).

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.

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) ]
  • Intermittent fasting compliance as measured by ketone laboratory testing [ Time Frame: Day 1 of cycle 1 (each cycle consisting of 21 days) ]
  • Intermittent fasting compliance as measured by IGF-1 laboratory testing [ Time Frame: Day 1 of cycle 1 (each cycle consisting of 21 days) ]
  • Intermittent fasting compliance as measured by insulin laboratory testing [ Time Frame: Day 1 of cycle 1 (each cycle consisting of 21 days) ]
  • 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) ]
  • Intermittent fasting compliance as measured by ketone laboratory testing [ Time Frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days) ]
  • 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) ]
  • Intermittent fasting compliance as measured by insulin laboratory testing [ Time Frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days) ]
  • 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) ]
  • Intermittent fasting compliance as measured by ketone laboratory testing [ Time Frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days) ]
  • 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) ]
  • Intermittent fasting compliance as measured by insulin laboratory testing [ Time Frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days) ]
  • Intermittent fasting compliance as measured by self-reported assessment [ Time Frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days) ]
  • Intermittent fasting compliance as measured by self-reported assessment [ Time Frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days) ]
  • Intermittent fasting compliance as measured by food diary [ Time Frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days) ]
  • Intermittent fasting compliance as measured by food diary [ Time Frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days) ]
  • Intermittent fasting compliance as measured by food diary [ Time Frame: Up to 12 weeks post intervention ]
  • Pre body composition [ Time Frame: Baseline ]
  • Post body composition [ Time Frame: Up to 12 weeks post intervention ]

Central Contacts and Locations

Central contacts

Michelle Kuznicki, MD

(216) 444-8811kuznicm@ccf.org

Jackie Ludwig

216 390-2492ludwigj@ccf.org

Locations

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

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.