RECRUITING

Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer

Quick Facts

Study Start:2024-07-11
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06386887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and above
  2. * Participants with confirmed diagnosis of epithelial ovarian cancer (EOC) by internal cytologic or histologic evaluation (including fallopian tube and primary peritoneal cancer)
  3. * Participant who had undergone laparoscopic evaluation or laparotomy for diagnosis but did not proceed with surgical debulking
  4. * Participants with stage III or IV EOC planned to undergo NACT or already receiving NACT (cycle 1)
  5. * Any invasive ovarian cancer histology
  6. * Normal cognitive function
  1. * Age \<18 years
  2. * Malignant complete or partial bowel obstruction confirmed on imaging.
  3. * Participants unable to provide informed consent.
  4. * BMI \<18
  5. * Participants diagnosed with severe malnutrition as assessed by study dietitian
  6. * Type I diabetes on insulin
  7. * Absence of pretreatment CT abdomen and pelvis imaging or \>4-6 weeks between imaging and cycle 1 of chemotherapy.

Contacts and Locations

Study Contact

Mariam AlHilli, MD
CONTACT
(216) 445-8090
ALHILLM@ccf.org
Jackie Ludwig
CONTACT
216 390-2492
ludwigj@ccf.org

Principal Investigator

Mariam AlHilli, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Mariam AlHilli, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-07-11
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Epithelial Ovarian Cancer