Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06386887

Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

Led by Case Comprehensive Cancer Center · Updated on 2026-05-07

20

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and above
  • Confirmed diagnosis of primary epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer)
  • Receiving platinum-based chemotherapy for ovarian cancer, including those with stage III or IV planned for neoadjuvant chemotherapy
  • Participants with stage III or IV following primary debulking surgery
  • Participants with recurrent epithelial ovarian cancer receiving platinum-based chemotherapy
  • Participants post neoadjuvant chemotherapy and interval debulking surgery receiving adjuvant chemotherapy
  • Any invasive ovarian cancer histology
  • Normal cognitive function
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Malignant complete or partial bowel obstruction confirmed by imaging
  • Unable to provide informed consent
  • Body mass index (BMI) less than 18
  • Severe malnutrition as assessed by study dietitian
  • Type I diabetes on insulin
  • No pretreatment CT abdomen and pelvis imaging or imaging older than 4-6 weeks before chemotherapy cycle 1

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Trial Site Locations

Total: 1 location

1

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

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

M

Michelle Kuznicki, MD

CONTACT

J

Jackie Ludwig

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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