Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

Official title

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

Overview

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.

Interventions

• Behavioral 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 d
• Drug 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 measures

• 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)]

Secondary outcome measures (12)

• Chemotherapy related toxicity at Cycle 2 [Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)]
• Chemotherapy related toxicity at Cycle 3 [Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)]
• Chemotherapy related toxicity at Cycle 4 [Time frame: Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days)]
• Chemotherapy related toxicity at post treatment [Time frame: Up to 12 weeks post intervention]
• ESAS Score at Enrollment [Time frame: At baseline]
• ESAS Score at Cycle 2 [Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)]
• ESAS Score at Cycle 3 [Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)]
• ESAS Score at Post Treatment [Time frame: Up to 12 weeks post intervention]
• SF-125 Score at Baseline [Time frame: At baseline]
• SF-125 Score at Cycle 2 [Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)]
• SF-125 Score at Cycle 3 [Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)]
• SF-125 Score at Post Treatment [Time frame: Up to 12 weeks post intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic — Cleveland

Identifiers

NCT: NCT06386887 · CASE1824

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗