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

NCT04065984 | Active Not Recruiting

• 1 other identifier: 242022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Rectal Cancer; Colo-rectal Cancer; Colon Cancer; Sarcopenia; Sarcopenic Obesity; Advanced Cancer; Recurrent Rectal Cancer

Keywords

Rectal Cancer; Colorectal Cancer; Recurrent Rectal Cancer; Advanced Rectal Cancer; Myopenia; Sarcopenia; Myosteatosis

Outcome Measures

Primary Outcomes (1)

• Mean muscle attenuation pre and postoperatively

  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.

  2 years

Secondary Outcomes (14)

• 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

Study Arms (2)

Neuro-Muscular electrical stimulation treatment arm

EXPERIMENTAL

Active muscle stimulation with a view that this will lead to muscle preservation through muscle fibre recruitment

Device: Microstim 2v2 Stimulator

Neuro-Muscular electrical stimulation Placebo arm

SHAM COMPARATOR

Stimulator set at a sub therapeutic threshold so as to not recruit muscle fibres

Device: Microstim 2v2 Stimulator

Interventions

Microstim 2v2 Stimulator DEVICE

Neuro-muscular electrical stimulator portable device (9v battery) connected to the skin participant over the muscle body of choice using self adhesive electro-gel pads. Treatment devices and placebo devices.

Neuro-Muscular electrical stimulation Placebo arm; Neuro-Muscular electrical stimulation treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

London North West University Healthcare NHS Trust

London, Greater London, HA1 3UJ, United Kingdom

Location

Related Publications (6)

• Malietzis G, Currie AC, Johns N, Fearon KC, Darzi A, Kennedy RH, Athanasiou T, Jenkins JT. Skeletal Muscle Changes After Elective Colorectal Cancer Resection: A Longitudinal Study. Ann Surg Oncol. 2016 Aug;23(8):2539-47. doi: 10.1245/s10434-016-5188-1. Epub 2016 Mar 22.

  PMID: 27006127 BACKGROUND

• Malietzis G, Johns N, Al-Hassi HO, Knight SC, Kennedy RH, Fearon KC, Aziz O, Jenkins JT. Low Muscularity and Myosteatosis Is Related to the Host Systemic Inflammatory Response in Patients Undergoing Surgery for Colorectal Cancer. Ann Surg. 2016 Feb;263(2):320-5. doi: 10.1097/SLA.0000000000001113.

  PMID: 25643288 BACKGROUND

• Malietzis G, Currie AC, Athanasiou T, Johns N, Anyamene N, Glynne-Jones R, Kennedy RH, Fearon KC, Jenkins JT. Influence of body composition profile on outcomes following colorectal cancer surgery. Br J Surg. 2016 Apr;103(5):572-80. doi: 10.1002/bjs.10075.

  PMID: 26994716 BACKGROUND

• Grande AJ, Silva V, Maddocks M. Exercise for cancer cachexia in adults: Executive summary of a Cochrane Collaboration systematic review. J Cachexia Sarcopenia Muscle. 2015 Sep;6(3):208-11. doi: 10.1002/jcsm.12055. Epub 2015 Jul 7.

  PMID: 26401466 BACKGROUND

• Maddocks M, Lewis M, Chauhan A, Manderson C, Hocknell J, Wilcock A. Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer. J Pain Symptom Manage. 2009 Dec;38(6):950-6. doi: 10.1016/j.jpainsymman.2009.05.011.

  PMID: 19748761 BACKGROUND

• Pring ET, Gould LE, Malietzis G, Lung P, Bharal M, Fadodun T, Bassett P, Naghibi M, Taylor C, Drami I, Chauhan D, Street T, Francis NK, Athanasiou T, Saxton JM, Jenkins JT; BiCyCLE Research Group. BiCyCLE NMES-neuromuscular electrical stimulation in the perioperative treatment of sarcopenia and myosteatosis in advanced rectal cancer patients: design and methodology of a phase II randomised controlled trial. Trials. 2021 Sep 15;22(1):621. doi: 10.1186/s13063-021-05573-2.

  PMID: 34526100 DERIVED

Related Links

• Trial Website

MeSH Terms

Conditions

Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Edward T Pring, BSc MRCS

  LNWUH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: August 22, 2019
• Study Start: April 14, 2019
• Primary Completion: March 6, 2021
• Study Completion: March 1, 2026
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)