Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 32 for:    Recruiting, Not yet recruiting, Available Studies | obesity | stimulation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065984
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
London North West Healthcare NHS Trust

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Colorectal Cancer Colon Cancer Colo-rectal Cancer Sarcopenia Sarcopenic Obesity Advanced Cancer Recurrent Rectal Cancer Device: Microstim 2v2 Stimulator Not Applicable

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 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.

The investigators are planning to stimulate the thigh and back muscles pre and post operatively in patients undergoing surgery for locally advanced rectal cancer using a device known as a neuromuscular electrical stimulator (NMES). This device mimics exercise in patients, who are unable to exercise fully. The investigators hypothesise that this will prevent the muscle loss normally seen in advanced cancer patients and even, potentially, increase muscle bulk. The investigators will compare this patient group to a control group of patients who are having the same surgery but will use a placebo stimulation protocol. The investigators will compare short and long term outcomes, differences in inflammation and quality of life in both these patient groups.

Neuro-Muscular Electrical Stimulation 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.

The investigators 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.

The purpose of this study is to see whether muscle bulk can be preserved and muscle quality maintained in partially immobile post operative advanced rectal cancer patients. This will be done by using a neuromuscular electrical stimulator (NMES) device called a Microstim 2v2 (Odstock Medical Ltd, Salisbury, UK). The investigators are doing this because it is known from previous research that patients with more muscle and better quality muscle have better outcomes following colorectal cancer surgery. It is also known from studies in the critically ill that NMES can successfully increase muscle and can act as a surrogate for exercise. The investigators aim to identify whether muscle bulk and quality can be increased and improved in these patients and indeed, whether this reduces inflammation, improves recovery, outcomes and Quality of Life. the investigators also want to see if patients find the device easy and acceptable to use.

This will be run as a single centre double blind randomised controlled phase II trial.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: BiCyCLE: Neuro-Muscular Electrical Stimulation (NMES) and Its Effect on Changes in Body Composition Following Surgery for Locally Advanced Rectal Cancer - a Single Centre Double Blind Randomised Controlled Phase II Clinical Trial
Actual Study Start Date : April 14, 2019
Estimated Primary Completion Date : March 6, 2021
Estimated Study Completion Date : March 1, 2026

Arm Intervention/treatment
Experimental: Neuro-Muscular electrical stimulation treatment arm
Active muscle stimulation with a view that this will lead to muscle preservation through muscle fibre recruitment
Device: Microstim 2v2 Stimulator
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.

Sham Comparator: Neuro-Muscular electrical stimulation Placebo arm
Stimulator set at a sub therapeutic threshold so as to not recruit muscle fibres
Device: Microstim 2v2 Stimulator
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.




Primary Outcome Measures :
  1. Mean muscle attenuation pre and postoperatively [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. CT derived muscle measurements [ Time Frame: 6 months ]
    The difference in Lumbar skeletal Muscle Index (LSMI=height / area of skeletal muscle in cm2 at L3) derived from the third lumbar vertebral axial level of pre and 3 to 6 month postoperative CT scans using SliceOmatic software version 5.0 with ABACS L3 Plug-in automation tool.

  2. CT derived fat measurements [ Time Frame: 6 months ]
    The difference in Visceral Adipose Tissue (cm2) derived from the third lumbar vertebral axial level of pre and 3 to 6 month postoperative CT scans using SliceOmatic software version 5.0 with ABACS L3 Plug-in automation tool.

  3. Pre and Post-operative systemic inflammation [ Time Frame: 6 months ]
    C-reactive protein (CRP)

  4. Pre and Post-operative systemic cellular immune response [ Time Frame: 6 months ]
    Neutrophil to Lymphocyte ratio (NLR)

  5. Short-term post surgical complications [ Time Frame: 6 months ]
    Clavien-Dindo Score for postoperative complications (1-5)

  6. Hospital Stay [ Time Frame: 6 months ]
    Length of hospital stay in days

  7. Quality of Life (General - EQ- 5D- 5L) [ Time Frame: 2 years ]

    EuroQol 5-level EQ-5D version, consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    Five dimensions are analysed: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored from 1 to 5 ranging from: no problems, slight problems, moderate problems, severe problems and extreme problems.

    The patient ticks a box corresponding to indicate their status within each dimension. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Post-operative quality of life at 6 months and 12 months following surgery using the validated quality of life questionnaire ED-5Q-5L will be assessed as described above.


  8. Quality of Life (Colorectal specific - EORTC QLQ - CR29) [ Time Frame: 2 years ]

    European Organisation for Research and Treatment of Cancer (EORTC) colorectal QoL module QLQ-CR29. The QLQ-CR29 contains 4 multi item scales and 19 single items assessing common symptoms and problems in colorectal cancer. The scales and single item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.

    Post-operative quality of life at 6 months and 12 months following surgery using the validated quality of life questionnaire EORTC QLQ - CR29


  9. Function [ Time Frame: 6 months ]
    Function as assessed by the Berg Balance scale, sit-to-stand and 6-minute walk test at baseline and approximately 3 months following surgery

  10. Thigh circumference [ Time Frame: 2 years ]
    Difference in thigh circumference both legs (at 15cm above the superior pole of the patella) preoperatively and at 3 month postoperatively.

  11. Bio-impedance measures of body composition [ Time Frame: 2 years ]
    Bio-impedance analysis (BIA) metrics at set time points (baseline, day two post operatively, day twenty-eight post operatively (if in hospital) day of discharge, first post-operative follow u appointment.

  12. Device satisfaction [ Time Frame: 10 weeks ]
    Patient satisfaction with using the NMES device.

  13. Device dose response [ Time Frame: 2 years ]
    Dose response to NMES utilising the patient compliance diary and CT derived data.

  14. Sequential CT changes in body composition [ Time Frame: 5 years ]
    Sequential changes measure on CT over a 5-year follow-up period following surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065984


Contacts
Layout table for location contacts
Contact: Edward T Pring, BSc MRCS 00 44 20 8869 4177 edward.pring@nhs.net
Contact: John T Jenkins, MD FRCS 00 44 20 8869 4177 i.jenkins@nhs.net

Locations
Layout table for location information
United Kingdom
London North West University Healthcare NHS Trust Recruiting
London, Greater London, United Kingdom, HA1 3UJ
Contact: Edward T Pring, BSc MRCS    00 44 20 8869 4177    edward.pring@nhs.net   
Contact: John T Jenkins, MD FRCS    00 44 20 8869 4177    i.jenkins@nhs.net   
Sponsors and Collaborators
London North West Healthcare NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Edward T Pring, BSc MRCS LNWUH NHS Trust

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT04065984     History of Changes
Other Study ID Numbers: 242022
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan at present for data sharing however patients will consent for fully anonymised data sharing to occur. No identifiable information will be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London North West Healthcare NHS Trust:
Rectal Cancer
Colorectal Cancer
Recurrent Rectal Cancer
Advanced Rectal Cancer
Myopenia
Sarcopenia
Myosteatosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Rectal Neoplasms
Sarcopenia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms