The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intermittent fasting compliance as measured by IGF-1 laboratory testing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age <18 years
- •Malignant complete or partial bowel obstruction confirmed on imaging.
- •Participants unable to provide informed consent.
- •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.
研究组 & 干预措施
Standard of Care
Participants will receive standard of care dietary recommendations and will provide a 3-day diet diary at study enrollment and during cycles 2 and 3.
干预措施: Neoadjuvant chemotherapy (Drug)
Intermittent Fasting
Participants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy.
干预措施: Neoadjuvant chemotherapy (Drug)
Intermittent Fasting
Participants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy.
干预措施: Intermittent Fasting (Behavioral)
结局指标
主要结局
Intermittent fasting compliance as measured by IGF-1 laboratory testing
时间窗: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.
Intermittent fasting compliance as measured by ketone laboratory testing
时间窗: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.
Intermittent fasting compliance as measured by food diary
时间窗: Up to 12 weeks post intervention
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Intermittent fasting compliance as measured by insulin laboratory testing
时间窗: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
Intermittent fasting compliance as measured by self-reported assessment
时间窗: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
Post body composition
时间窗: Up to 12 weeks post intervention
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
Intermittent fasting compliance as measured by serum glucose laboratory testing
时间窗: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.
Pre body composition
时间窗: Baseline
Pre- and post- treatment body composition will be assessed by Computed Tomography scans.
Intermittent fasting compliance as measured by serum glucose laboratory testing
时间窗: Day 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.
Intermittent fasting compliance as measured by ketone laboratory testing
时间窗: Day 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.
Intermittent fasting compliance as measured by IGF-1 laboratory testing
时间窗: Day 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.
Intermittent fasting compliance as measured by insulin laboratory testing
时间窗: Day 1 of cycle 1 (each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
Intermittent fasting compliance as measured by serum glucose laboratory testing
时间窗: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.
Intermittent fasting compliance as measured by ketone laboratory testing
时间窗: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy. which will be measured by metabolic laboratory tests (serum glucose, ketone, IGF-1, and insulin) prior to each chemotherapy.
Intermittent fasting compliance as measured by IGF-1 laboratory testing
时间窗: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.
Intermittent fasting compliance as measured by insulin laboratory testing
时间窗: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.
Intermittent fasting compliance as measured by self-reported assessment
时间窗: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.
Intermittent fasting compliance as measured by food diary
时间窗: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
Intermittent fasting compliance as measured by food diary
时间窗: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.
次要结局
- Chemotherapy related toxicity at Cycle 2(Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days))
- ESAS Score at Enrollment(At baseline)
- Pre Functional Assessment (FACT-O) Score at Baseline(Up to 12 weeks post intervention)
- AIM Survey Score at Cycle 2(Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days))
- Chemotherapy related toxicity at Cycle 4(Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days))
- Chemotherapy related toxicity at post treatment(Up to 12 weeks post intervention)
- SF-125 Score at Post Treatment(Up to 12 weeks post intervention)
- AIM Survey Score at Cycle 3(Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days))
- Chemotherapy related toxicity at Cycle 3(Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days))
- ESAS Score at Cycle 3(Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days))
- SF-125 Score at Baseline(At baseline)
- ESAS Score at Cycle 2(Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days))
- ESAS Score at Post Treatment(Up to 12 weeks post intervention)
- SF-125 Score at Cycle 2(Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days))
- SF-125 Score at Cycle 3(Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days))
- Post Quality of Life (QLQ-C30) Score Post Treatment(Up to 12 weeks post intervention)
- Post Functional Assessment (FACT-O) Score Post Treatment(Up to 12 weeks post intervention)
- AIM Survey Score at Post Treatment(Up to 12 weeks post intervention)
- Pre Quality of Life (QLQ-C30) Score at Baseline(At baseline)