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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 range18 Years

SexALL

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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.

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