ACTRN12624000166572尚未招募Unknown
A pilot study to investigate the feasibility of a combined exercise and nutrition prehabilitation program for patients with endometrial cancer scheduled for surgery
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1.Low grade (grade 1) endometrioid endometrial adenocarcinoma
- •2.Presumed early stage (Federation of Gynecology and Obstetrics stage 1A) on physical
- •examination and imaging (CT chest, abdomen, and pelvis)
- •3.At least one of the following cardiovascular risk factors: overweight (BMI greater than or
- •equal to 25kg/m2) or obese (BMI greater than or equal to 30kg/m2), hypertension, type
- •2 diabetes, hypercholesterolaemia, self-reported physical inactivity (less than 150
- •minutes per week of moderate activity such as walking, gardening, swimming, cycling,
- •gym), smoking
- •4.Planned to undergo definitive surgery (total hysterectomy, bilateral salpingo-
- •oophorectomy +/- sentinel lymph node biopsies)
- •5.Age 18 years or older
- •6.Able to understand study requirements, attend regular appointments with the exercise
- •physiologist and dietitian, and complete the home exercise logbook
- •7.European Cooperative Oncology Group (ECOG) performance status less than or equal
排除标准
- •1.Medical contraindication to exercise or the use of a very low-calorie diet, including
- •physical impairments, lactation, presence of porphyria, severe hepatic disease,
- •advanced renal disease, unstable cardiac disease (recent myocardial infarction or
- •unstable angina), type 1 diabetes mellitus, overt psychosis, alcoholism, or drug abuse
- •2.Patients on lithium, corticosteroids, anticonvulsants (although not a contraindication to
- •Optifast, requires extra monitoring beyond the scope of this study)
- •3.Evidence of extra-uterine disease clinically or on medical imaging
- •4.Histological cell types including serous, clear cell, carcinosarcoma, sarcoma, de-
- •differentiated
- •5.Moderately differentiated or poorly differentiated (grades 2 and 3) endometrioid
- •adenocarcinoma
- •6.Grade 1 endometrioid adenocarcinoma where the treatment plan is for fertility
- •preservation/conservative management
- •7.Inability to give informed consent
- •8.European Cooperative Oncology Group (ECOG) performance status greater than or
研究者
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