BiCyCLE: Neuro-Muscular Electrical Stimulation (NMES) and Its Effect on Changes in Body Composition Following Surgery for Locally Advanced Rectal Cancer - a Single Centre Double Blind Randomised Controlled Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Mean muscle attenuation pre and postoperatively
研究概览
简要总结
Muscle is lost as part of the rectal cancer disease process. Surgery to treat rectal cancer and its subsequent immobility leads to increased muscle loss. Neuromuscular electrical stimulation (NMES) has been shown in previous studies in the critically ill to maintain muscle mass. The investigators aim to examine whether NMES use in the pre and postoperative setting preserves muscle mass, speeds up recovery and improves outcomes in advanced rectal cancer patients undergoing curative surgery. This is a phase II double blind randomised controlled clinical trial.
详细描述
Myopenia (muscle wasting) occurs as part of the disease process of colorectal cancer, when coupled with the physiological demands and immobility of major surgery there is an even more profound loss in muscle mass.
Evidence suggests that patients who have greater muscle mass and better muscle quality have better post operative outcomes, fewer complications and longer survival. Patients who have pelvic surgery (complex major surgery to remove some or all the pelvic organs involved in the local spread cancer) for locally advanced rectal cancer (cancer of the last part of the large bowel) are highly immobile post operatively.
The investigators are planning to stimulate the thigh and back muscles pre and post operatively in patients undergoing surgery for locally advanced rectal cancer using a device known as a neuromuscular electrical stimulator (NMES). This device mimics exercise in patients, who are unable to exercise fully. The investigators hypothesise that this will prevent the muscle loss normally seen in advanced cancer patients and even, potentially, increase muscle bulk. The investigators will compare this patient group to a control group of patients who are having the same surgery but will use a placebo stimulation protocol. The investigators will compare short and long term outcomes, differences in inflammation and quality of life in both these patient groups.
Neuro-Muscular Electrical Stimulation has been used successfully to help provide physiotherapy in critically ill patients, in earlier studies it has shown preservation of muscle in cancer patients too.
The investigators want to identify whether NMES, as an adjunct to standard parenteral nutritional support and physiotherapy, can help maintain or even increase lean body mass and exert the anti-inflammatory effect of exercise. We want to see if using this device improves quality of life post operatively and improves patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will either receive a device providing active treatment levels of stimulation or a placebo device providing sub therapeutic electrical stimulation.
The main outcome is change in muscle mass of CT at 3 to 6 months. These scans will be assessed by a radiologist using automated software, the radiologist is blinded to which trial arm the patient was in.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 and above
- •Male or female
- •Primary or recurrent locally advanced rectal cancer amenable to elective radical exenterative surgery
- •ASA grade I-III
- •Able and willing to consent
- •Participation in other concurrent trials is acceptable - following discussion with trial team of both studies.
排除标准
- •Lack of patient consent
- •Wide spread metastases not amenable to curative resection
- •Contraindication to NMES (see appendix 6)
- •Pre existing neuromuscular degenerative disease
- •Participation in other trials where agreement on participation not made in advance by trial teams
- •Patients with solitary colon cancer above the level of the peritoneal reflexion which does not require complex pelvic surgery.
结局指标
主要结局
Mean muscle attenuation pre and postoperatively
时间窗: 2 years
The difference in mean muscle attenuation (MA) measured in Hounsfield units between the pre- operative and 3 month post-operative CT scan in the NMES treatment group and the placebo NMES group.
次要结局
- CT derived muscle measurements(6 months)
- CT derived fat measurements(6 months)
- Pre and Post-operative systemic inflammation(6 months)
- Pre and Post-operative systemic cellular immune response(6 months)
- Short-term post surgical complications(6 months)
- Device satisfaction(10 weeks)
- Device dose response(2 years)
- Hospital Stay(6 months)
- Quality of Life (General - EQ- 5D- 5L)(2 years)
- Sequential CT changes in body composition(5 years)
- Quality of Life (Colorectal specific - EORTC QLQ - CR29)(2 years)
- Function(6 months)
- Thigh circumference(2 years)
- Bio-impedance measures of body composition(2 years)