BiCyCLe NMES - Electric Bike
Research type
Research Study
Full title
Body Composition Manipulation in Colorectal Cancer (BiCyCLE): Neuro-Muscular Electrical Stimulation (NMES) and its effect on the systemic inflammatory response and changes in body composition following radical surgery for locally advanced rectal cancer – a single centre double blind randomised controlled phase II clinical trial
IRAS ID
242022
Contact name
John Jenkins
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
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.
We are planning to stimulate the thigh and back muscles of patients undergoing surgery for locally advanced rectal cancer using a device called the Microstim 2v2 which is a neuromuscular electrical stimulator. This device mimics exercise in patients, who are unable to exercise fully. We predict that this will prevent the muscle loss we normally see in our advanced cancer patients and even, potentially, increase muscle bulk. We will compare this patient group to a control group of patients who are having the same surgery but will use a placebo stimulation protocol. We will compare short and long term outcomes, differences in inflammation and quality of life in both these groups.
Neuro-Muscular Electrical Stimulation (NMES) 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. As such we are currently using the device in select advanced cancer patients.
We 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.
REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0259
Date of REC Opinion
13 Mar 2019
REC opinion
Further Information Favourable Opinion