Clinical trial NCT06386887: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Cancer
Keywords: Short term fasting
Intermittent fasting
Intermittent energy restriction (IER)
Fasting mimicking diet (FMD)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm, randomized, controlled study.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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)
* 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 chemotherapy including neoadjuvant chemotherapy
* Participants with recurrent epithelial ovarian cancer who will receive platinum-based 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.

Primary outcomes:
measure: Intermittent fasting compliance as measured by serum glucose laboratory testing
timeFrame: Day 1 of cycle 1 (each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by ketone laboratory testing
timeFrame: Day 1 of cycle 1 (each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing
timeFrame: Day 1 of cycle 1 (each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by insulin laboratory testing
timeFrame: Day 1 of cycle 1 (each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by serum glucose laboratory testing
timeFrame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by ketone laboratory testing
timeFrame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing
timeFrame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by insulin laboratory testing
timeFrame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by serum glucose laboratory testing
timeFrame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by ketone laboratory testing
timeFrame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing
timeFrame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by insulin laboratory testing
timeFrame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by self-reported assessment
timeFrame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by self-reported assessment
timeFrame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by food diary
timeFrame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by food diary
timeFrame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
measure: Intermittent fasting compliance as measured by food diary
timeFrame: Up to 12 weeks post intervention
measure: Pre body composition
timeFrame: Baseline
measure: Post body composition
timeFrame: Up to 12 weeks post intervention
Secondary outcomes:
measure: Chemotherapy related toxicity at Cycle 2
timeFrame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
measure: Chemotherapy related toxicity at Cycle 3
timeFrame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
measure: Chemotherapy related toxicity at Cycle 4
timeFrame: Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days)
measure: Chemotherapy related toxicity at post treatment
timeFrame: Up to 12 weeks post intervention
measure: ESAS Score at Enrollment
timeFrame: At baseline
measure: ESAS Score at Cycle 2
timeFrame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
measure: ESAS Score at Cycle 3
timeFrame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
measure: ESAS Score at Post Treatment
timeFrame: Up to 12 weeks post intervention
measure: SF-125 Score at Baseline
timeFrame: At baseline
measure: SF-125 Score at Cycle 2
timeFrame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
measure: SF-125 Score at Cycle 3
timeFrame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
measure: SF-125 Score at Post Treatment
timeFrame: Up to 12 weeks post intervention
measure: Pre Quality of Life (QLQ-C30) Score at Baseline
timeFrame: At baseline
measure: Post Quality of Life (QLQ-C30) Score Post Treatment
timeFrame: Up to 12 weeks post intervention
measure: Pre Functional Assessment (FACT-O) Score at Baseline
timeFrame: Up to 12 weeks post intervention
measure: Post Functional Assessment (FACT-O) Score Post Treatment
timeFrame: Up to 12 weeks post intervention
measure: AIM Survey Score at Cycle 2
timeFrame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
measure: AIM Survey Score at Cycle 3
timeFrame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
measure: AIM Survey Score at Post Treatment
timeFrame: Up to 12 weeks post intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mariam AlHilli, MD
role: PRINCIPAL_INVESTIGATOR
References: