Rectal CancerBiCyCLE-NMESNCT04065984
Body Composition Manipulation in CoLorectal cancEr (BiCyCLE): Neuromuscular Electrical Stimulation (NMES)
A study testing Microstim 2v2 Stimulator in people with Rectal Cancer and Colorectal Cancer, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Colorectal Cancer, Colon Cancer
- What is being tested?
- Microstim 2v2 Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2019to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London North West University Healthcare NHS Trust
London, Greater London, HA1 3UJ
About this study
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
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.
Read the 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.
- Conditions
- Rectal Cancer, Colorectal Cancer, Colon Cancer, Colo-rectal Cancer, Sarcopenia, Sarcopenic Obesity
- Being tested
- Microstim 2v2 Stimulator
- Keywords
- Rectal Cancer, Colorectal Cancer, Recurrent Rectal Cancer, Advanced Rectal Cancer, Myopenia, Sarcopenia, Myosteatosis
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms, Colonic Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microstim 2v2 StimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-Muscular electrical stimulation treatment arm | Experimental | Active muscle stimulation with a view that this will lead to muscle preservation through muscle fibre recruitment Receives: 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 Receives: Device: Microstim 2v2 Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (14)
CT derived muscle measurements
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.
Measured: 6 months
CT derived fat measurements
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.
Measured: 6 months
Pre and Post-operative systemic inflammation
C-reactive protein (CRP)
Measured: 6 months
Pre and Post-operative systemic cellular immune response
Neutrophil to Lymphocyte ratio (NLR)
Measured: 6 months
Short-term post surgical complications
Clavien-Dindo Score for postoperative complications (1-5)
Measured: 6 months
Hospital Stay
Length of hospital stay in days
Measured: 6 months
Quality of Life (General - EQ- 5D- 5L)
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.
Measured: 2 years
Quality of Life (Colorectal specific - EORTC QLQ - CR29)
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
Measured: 2 years
Function
Function as assessed by the Berg Balance scale, sit-to-stand and 6-minute walk test at baseline and approximately 3 months following surgery
Measured: 6 months
Thigh circumference
Difference in thigh circumference both legs (at 15cm above the superior pole of the patella) preoperatively and at 3 month postoperatively.
Measured: 2 years
Bio-impedance measures of body composition
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.
Measured: 2 years
Device satisfaction
Patient satisfaction with using the NMES device.
Measured: 10 weeks
Device dose response
Dose response to NMES utilising the patient compliance diary and CT derived data.
Measured: 2 years
Sequential CT changes in body composition
Sequential changes measure on CT over a 5-year follow-up period following surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start14 Apr 2019
- Primary completion6 Mar 2021
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward T Pring, BSc MRCS, Principal investigator, LNWUH NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065984
- Sponsor's protocol ID
- 242022
- Acronym
- BiCyCLE-NMES
- Status last verified
- Oct 2021
- First submitted
- 3 Apr 2019
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 27006127Malietzis 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.
PubMed 25643288Malietzis 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.
PubMed 26994716Grande 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.
PubMed 26401466Maddocks 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.
PubMed 19748761Pring 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.
PubMed 34526100
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04065984
- Acronym / sponsor ID
- BiCyCLE-NMES / 242022
- Conditions
- Rectal Cancer, Colorectal Cancer, Colon Cancer, Colo-rectal Cancer, Sarcopenia, Sarcopenic Obesity
- Keywords
- Rectal Cancer, Colorectal Cancer, Recurrent Rectal Cancer, Advanced Rectal Cancer, Myopenia, Sarcopenia, Myosteatosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro-Muscular electrical stimulation treatment arm | Experimental | Device: Microstim 2v2 StimulatorActive muscle stimulation with a view that this will lead to muscle preservation through muscle fibre recruitment |
| Neuro-Muscular electrical stimulation Placebo arm | Sham comparator | Device: Microstim 2v2 StimulatorStimulator set at a sub therapeutic threshold so as to not recruit muscle fibres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microstim 2v2 StimulatorNeuro-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. | Device | Neuro-Muscular electrical stimulation Placebo arm, Neuro-Muscular electrical stimulation treatment arm |
Primary outcome
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.
14 secondary outcomes
CT derived muscle measurements
Time frame: 6 months
CT derived fat measurements
Time frame: 6 months
Pre and Post-operative systemic inflammation
Time frame: 6 months
Pre and Post-operative systemic cellular immune response
Time frame: 6 months
Short-term post surgical complications
Time frame: 6 months
Hospital Stay
Time frame: 6 months
Quality of Life (General - EQ- 5D- 5L)
Time frame: 2 years
Quality of Life (Colorectal specific - EORTC QLQ - CR29)
Time frame: 2 years
Function
Time frame: 6 months
Thigh circumference
Time frame: 2 years
Bio-impedance measures of body composition
Time frame: 2 years
Device satisfaction
Time frame: 10 weeks
Device dose response
Time frame: 2 years
Sequential CT changes in body composition
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 27006127Malietzis 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.
- Background: PubMed 25643288Malietzis 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.
- Background: PubMed 26994716Malietzis 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.
- Background: PubMed 26401466Grande 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.
- Background: PubMed 19748761Maddocks 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.
- Derived from this study: PubMed 34526100Pring 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward T Pring, BSc MRCS principal investigator
LNWUH NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microstim 2v2 Stimulator in people with Rectal Cancer and Colorectal Cancer, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean muscle attenuation pre and postoperatively (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065984, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.