Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

Trial Title: Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

NCT ID: NCT06386887

Condition: Epithelial Ovarian Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Conditions: Keywords:
Short term fasting
Intermittent fasting
Intermittent energy restriction (IER)
Fasting mimicking diet (FMD)

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Two arm, randomized, controlled study.

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Behavioral
Intervention name: Intermittent Fasting
Description: 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).
Arm group label: Intermittent Fasting

Other name: Time restricted eating

Intervention type: Drug
Intervention name: Neoadjuvant chemotherapy
Description: 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.
Arm group label: Intermittent Fasting
Arm group label: Standard of Care

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.

Detailed description: The quality of diet can affect the biology of cancer. For example, evidence implies a high fat/ Western diet may impose adverse events on ovarian cancer outcomes, and the potential that the gut microbiome alterations secondary to dietary changes may impact tumor responsiveness to treatment and outcomes. This study seeks to clarify the effect of dietary intervention on the tumor and gut microbiome and ovarian cancer biology. The objectives of this study include: - Primary: To test the feasibility and safety of IF during neoadjuvant chemotherapy (including effects on body composition) - Secondary: To measure the effects of IF on participant reported outcomes, chemotherapy toxicity and quality of life. - Exploratory: To test the effect of IF on pathologic response, systemic inflammatory and immune responses, microbial diversity and metabolic pathway alterations.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age 18 years and above - Participants with confirmed diagnosis of epithelial ovarian cancer (EOC) by internal cytologic or histologic evaluation (including fallopian tube and primary peritoneal cancer) - Participant who had undergone laparoscopic evaluation or laparotomy for diagnosis but did not proceed with surgical debulking - Participants with stage III or IV EOC planned to undergo NACT or already receiving NACT (cycle 1) - 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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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

Address:
City: Cleveland
Zip: 44195
Country: United States

Status: Recruiting

Contact:
Last name: Mariam AlHilli, MD

Start date: July 11, 2024

Completion date: January 1, 2026

Lead sponsor:
Agency: Case Comprehensive Cancer Center
Agency class: Other

Source: Case Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06386887