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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

Who can join

Ages 18 and older · Women

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.

About the study

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.

What is being tested

• Intermittent Fasting (behavioral)
• Neoadjuvant chemotherapy (drug)

Sponsor: Case Comprehensive Cancer Center · Participants: 20 · Started: Jul 11, 2024

Contact the study team

• Michelle Kuznicki, MD · Phone: (216) 444-8811
• Jackie Ludwig · Phone: 216 390-2492

Official record on ClinicalTrials.gov — NCT06386887

Locations in the U.S.

Conditions

• Ovarian Epithelial Carcinoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.