UnknownNot Applicable

Body Composition Manipulation in CoLorectal cancEr (BiCyCLE): Neuromuscular Electrical Stimulation (NMES)

United Kingdom46 participantsStarted 2019-04-14

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean muscle attenuation pre and postoperatively

Timeframe: 2 years

Trial details

NCT IDNCT04065984

SponsorLondon North West Healthcare NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-06

View on ClinicalTrials.gov More Rectal Cancer trials