Status:
ACTIVE_NOT_RECRUITING
Body Composition Manipulation in CoLorectal cancEr (BiCyCLE): Neuromuscular Electrical Stimulation (NMES)
Lead Sponsor:
London North West Healthcare NHS Trust
Conditions:
Rectal Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) ha...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04065984
Start Date
April 14 2019
End Date
March 1 2026
Last Update
October 29 2021
Active Locations (1)
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1
London North West University Healthcare NHS Trust
London, Greater London, United Kingdom, HA1 3UJ