Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Chemotherapy completion rate (relative dose intensity)
研究概览
简要总结
An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami.
Participants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm.
Study assessments will be conducted at baseline, post-chemotherapy/end of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery.
Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.
详细描述
200 women with newly diagnosed ovarian or endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. If women are interested and eligible, the study team will obtain consent and collect baseline data. Participants will be randomized to an exercise and medical nutrition intervention (18 weeks dependent on length of chemotherapy) or usual care throughout therapy. After the standard 6 cycles of chemotherapy (~18 weeks), a post-chemotherapy/end of intervention visit will be conducted. Follow-up assessments will be at standard of care visits (12-months post-diagnosis). Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.
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)
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
- •have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV OR have a diagnosis of advanced or metastatic endometrial carcinoma (including carcinosarcoma) AND their treatment regimen includes carboplatin and taxane (or equivalent)
- •be scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy
- •be physically able to walk without a walking aid (e.g. cane or walker)
- •be able to complete forms, understand instructions and read intervention book in English or Spanish
- •agree to be randomly assigned to either group
- •have clearance from oncologist to participate
- •be ≥ 18 years of age
排除标准
- •having already completed a 2nd cycle of chemotherapy
- •already practicing dietary (>7 servings of fruits and vegetables per day) OR physical activity guidelines (≥150 min per week of moderate to vigorous exercise and resistance training two times per week) since diagnosis
- •pregnancy or intention to become pregnant
- •recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction <40%
- •presence of dementia or major psychiatric disease
- •in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments)
- •receiving external beam radiation
研究组 & 干预措施
Control
Contact limited to study assessments.
Exercise and medical nutrition
Over the intervention period (18 weeks on average - dependent on length of chemotherapy) women in the intervention arm will receive weekly counseling sessions, the study dietitian and exercise trainer will each conduct weekly sessions to assist the participants in achieving the diet and exercise study goals.
干预措施: Exercise and medical nutrition (Behavioral)
结局指标
主要结局
Chemotherapy completion rate (relative dose intensity)
时间窗: Through end of first line chemotherapy, an average of 5 months
Chemotherapy completion rate will be assessed as the average relative dose intensity for the originally planned regimen based on standard formulas. This will be measured using the number and percent of patients requiring dose-adjustments, dose-delays, reason for dose.
次要结局
- Change in Physical activity - subjective measure(Through study completion, an average of 1 year)
- Change in Skeletal muscle mass(Through study completion, an average of 1 year)
- Change in Muscle Mass assessed using D3Creatine dilution method(Through end of first line chemotherapy, an average of 5 months.)
- Change in Healthy Eating Index-2020 (24-hour recall)(Through study completion, an average of 1 year)
- Change in Healthy Eating Index-2020 (FFQ)(Through study completion, an average of 1 year)
- Change in Physical activity - objective measure(Through study completion, an average of 1 year)
- Change in Neuropathy(Through study completion, an average of 1 year)
- Change in Cognitive function(Through study completion, an average of 1 year)
- Change in Arthralgia(Through study completion, an average of 1 year)
- Change in GI disturbance(Through study completion, an average of 1 year)
- Change in lower leg lymphedema(Through study completion, an average of 1 year)
- Change in BMI(Through study completion, an average of 1 year)
- Change in waist circumference(Through study completion, an average of 1 year)
- Change in Skin Carotenoids(Through study completion, an average of 1 year)
- Change in Fitness(Through study completion, an average of 1 year)
- Change in grip strength(Through study completion, an average of 1 year)
- Change in blood biomarkers(Through study completion, an average of 1 year)
- Change in financial toxicity(Through study completion, an average of 1 year)
- Change in level of function and ability to perform specific tasks(Through study completion, an average of 1 year)
- Change in Social Support(Through study completion, an average of 1 year)
- Change in Social Activity(Through study completion, an average of 1 year)
- Change in Quality of life (SF-36)(Through study completion, an average of 1 year)
- Change in Sleep Quality(Through study completion, an average of 1 year)
- Change in Fatigue(Through study completion, an average of 1 year)
- Change in symptoms of chemotherapy assessed using the Common Terminology Criteria for Adverse Events (CTCAE)(Through end of chemotherapy, an average of 5 months.)