SurgeryPOEMS2NCT06964438
Postoperative Electrical Muscle Stimulation Two
A study testing Neuromuscular Electrical Stimulation and Protein supplement drink in people with Surgery and Colorectal Cancer, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Undesirable loss of skeletal muscle mass (atrophy) is a common feature of many diseases as well as ageing, bed rest and physical inactivity. Losing muscle can lead to a reduction in one's ability to perform physical activities, and reduce independence and overall health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Colorectal Cancer, Muscle Atrophy
- What is being tested?
- Neuromuscular Electrical Stimulation and Protein supplement drink
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients (age 18 or over at the time of diagnosis made at MDT (multi-disciplinary team meeting)
- MDT outcome of colorectal or gastric cancer or non-invasive neoplasia (tissue-proven, or radiologically diagnosed and clinically suspected) with the intention to treat with curative abdominal surgery
- Agreed management plan for open or minimally invasive (laparoscopic or robot assisted) segmental abdominal (colonic or gastric) resection at the Royal Derby Hospital
- Sufficient mobility and fitness to complete normal ERAS (enhanced recovery after surgery) protocols following surgery
- Basic conversational spoken English language
- Ability to give informed consent
Who cannot join
- Upper GI (gastrointestinal) cancer requiring thoracotomy/thoracoscopy
- Pre-existing neuromuscular disease (including Parkinsons disease)
- Pacemaker, implantable cardiac defibrillator or other implanted nerve stimulator device
- Metal prostheses or other metal-work in either upper legs (hip/knee/femur)
- Dementia or other cognitive problem or language barrier causing an inability to follow instructions and operate NMES machine
- Inability to give informed consent
Show all 20Show fewer
- Disability preventing completion of ERAS after surgery (requiring Zimmer frame/wheeled frame/wheelchair to mobilise or bed-bound)
- Peripheral vascular disease
- Epilepsy
- Pre-existing diagnosis of chronic kidney disease or estimated glomerular filtration rate <60 on screening visit
- Pre-existing diagnosis of liver disease
- Intubation or intensive care admission during study period (between day 0-5 post-op); (surgical high dependency unit patients will be included)
- Return to theatre for surgical complication within first 5-days post operation
- History of rhabdomyolysis
- Pregnancy
- Deep vein thrombosis within past 6-months
- Allergy to whey protein
- Patient refusal of whey protein products on grounds of dietary requirements or intolerance
- Participating in another clinical trial concurrently or within the last 6 months
- Known infection with blood borne virus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Beth Phillips, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE
About this study
Official title: A Three-Arm Randomised Controlled Trial to Establish Effectiveness of NMES With or Without Protein Supplementation to Preserve Muscle Mass and Strength and Improve Functional Outcomes After Abdominal Surgery for GI Cancer
Undesirable loss of skeletal muscle mass (atrophy) is a common feature of many diseases as well as ageing, bed rest and physical inactivity. Losing muscle can lead to a reduction in one's ability to perform physical activities, and reduce independence and overall health. Muscle mass loss occurs very quickly (i.e., within a few days) after surgery.
The investigators previous work has shown that neuromuscular electrical stimulation (NMES) of the thigh muscles on one side of the body can help maintain muscle mass and strength on the stimulated side after surgery. Since then, additional work has been carried out to find the most effective form of stimulation to build muscle.
The current study aims to use this refined stimulation protocol in a clinical trial on the wards after major abdominal surgery. The intervention will involve delivering stimulation to both thighs in the few days after surgery, so that the investigators can assess whether this stimulation can preserve muscle mass and strength, and also, patients' ability to perform physical activities after surgery. In addition, the study will aim to find out whether any benefit provided by electrical stimulation can be increased further by taking a protein supplement at the same time.
Read the detailed description
The main objective of this trial is to assess whether neuromuscular stimulation (NMES) can minimise muscle loss following abdominal surgery for cancer; and whether such effect is further improved by simultaneous protein supplementation.
The main questions it aims to answer are:
- Does NMES training reduce the volume of muscle lost from the vastus lateralis (VL) muscle (in the thigh) after surgery as measured on ultrasound scan 5 days after surgery?
- Does NMES training together with protein supplementation lead to greater reduction of VL muscle volume loss on ultrasound 5 days after surgery then NMES alone?
Researchers will allocate participants into three groups (using a randomisation software).
All participants will visit the hospital once before surgery for starting point measurements including ultrasound.
Whilst they are in hospital, from the first until the fourth day after surgery, they will have the following interventions:
- Group 1 (the control group) will receive usual post-operative care with no additional interventions;
- Group 2 will receive normal postoperative care and twice daily NMES training sessions and a flavoured (placebo) drink
- Group 3 will receive normal post operative care as well as twice daily NMES training sessions and two protein rich drinks per day.
On the fifth day after surgery all participants will have repeat measurements including ultrasound to assess the extent of muscle loss they had since surgery.
- Conditions
- Surgery, Colorectal Cancer, Muscle Atrophy, Cancer Gi
- Being tested
- Neuromuscular Electrical Stimulation, Protein supplement drink
- Keywords
- electrical stimulation, neuromuscular electrical stimulation, NMES, rehabilitation, general surgery, colorectal surgery, laparotomy, laparoscopy, postoperative recovery, gastrointestinal cancer, gastrointestinal surgery
- Medical subject headings
- Colorectal Neoplasms, Muscular Atrophy, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationDevice
Also called NMES, electrical stimulation, ES, electrical muscle stimulation
Neuromuscular Electrical Stimulation training twice daily (30 minutes per session), during postoperative days 1-4. The training will be carried out using a handheld device. Training will be carried out by the participant themselves, with researcher supervision until independently able to do so.
Protein supplement drinkDietary supplement
Whey protein isolate drink, to provide a total of 60 g protein per day (2 x30 g).
The supplement will be provided in a powder form to participants. Participants will be asked to consume the supplement around the time of NMES training.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Control | No intervention | Standard postoperative care days 1-4 |
| Group 2 - NMES (no protein drink) | Experimental | Standard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS placebo drink twice daily (no protein supplement) Receives: Device: Neuromuscular Electrical Stimulation |
| Group 3 - NMES + protein drink | Experimental | Standard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS protein drink twice daily Receives: Device: Neuromuscular Electrical Stimulation; Dietary Supplement: Protein supplement drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative vastus lateralis (VL) muscle mass loss
Vastus lateralis (VL) muscle mass loss as measured on ultrasound cross sectional area
Measured: Pre-operatively and 5 days post-operatively
Secondary outcomes (12)
Post-operative knee extensor strength losses
Determined by knee-extensor strength via dynamometry.
Measured: Pre-operatively and 5 days post-operatively
Post-operative functional losses determined by short physical performance battery standardized physical function assessment tool
short physical performance battery
Measured: Pre-operatively and 5 days post-operatively
Post-operative functional losses determined by Timed Up and Go standardized physical function assessment tool
Timed up and go,
Measured: Pre-operatively and 5 days post-operatively
Post-operative functional losses determined by 6 minute walk test standardized physical function assessment tool
6 minute walk test
Measured: Pre-operatively and 5 days post-operatively
Post-operative changes in muscle architecture as measured by pennation angle
Pennation angle on VL US
Measured: Pre-operatively and 5 days post-operatively
Post-operative changes in muscle architecture as measured by fascicle length
fascicle length on VL Ultrasound
Measured: Pre-operatively and 5 days post-operatively
Post-operative declines in neuromuscular function
Determined via surface electromyography
Measured: Pre-operatively and 5 days post-operatively
Post-operative loss of independence and quality of life
Measured using the EuroQoL-5D questionnaire. The EuroQoL-5D-3L questionnaire is a standardised measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. It generates a simple descriptive profile and a single summary index value for health status.
Measured: Pre-operatively, 5 days post-operatively and 28 days post-operatively
Physical activity profiles of patients following major GI surgery
Measured using a thigh-worn accelerometer
Measured: Days 1-4 post operatively
Circulating amino acid profiles
Blood samples to assess circulatory amino acid levels
Measured: Pre-operatively, and on day 1 and 5 post-operatively
Systemic markers of inflammation
Blood samples to assess inflammatory marker levels
Measured: Pre-operatively, and on day 1 and 5 post-operatively
Post-operative vastus lateralis (VL) muscle mass loss
Vastus lateralis (VL) muscle mass loss as measured on ultrasound muscle thickness
Measured: Pre-operatively and 5 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start5 Jun 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964438
- Sponsor's protocol ID
- 24058
- Other IDs
- 347923
- Acronym
- POEMS2
- Status last verified
- May 2026
- First submitted
- 22 Apr 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Arm Randomised Controlled Trial to Establish Effectiveness of NMES With or Without Protein Supplementation to Preserve Muscle Mass and Strength and Improve Functional Outcomes After Abdominal Surgery for GI Cancer
- ClinicalTrials.gov ID
- NCT06964438
- Acronym / sponsor ID
- POEMS2 / 24058
- Conditions
- Surgery, Colorectal Cancer, Muscle Atrophy, Cancer Gi
- Keywords
- electrical stimulation, neuromuscular electrical stimulation, NMES, rehabilitation, general surgery, colorectal surgery, laparotomy, laparoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 May 2025 (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.
Undesirable loss of skeletal muscle mass (atrophy) is a common feature of many diseases as well as ageing, bed rest and physical inactivity. Losing muscle can lead to a reduction in one's ability to perform physical activities, and reduce independence and overall health. Muscle mass loss occurs very quickly (i.e., within a few days) after surgery.
The investigators previous work has shown that neuromuscular electrical stimulation (NMES) of the thigh muscles on one side of the body can help maintain muscle mass and strength on the stimulated side after surgery. Since then, additional work has been carried out to find the most effective form of stimulation to build muscle.
The current study aims to use this refined stimulation protocol in a clinical trial on the wards after major abdominal surgery. The intervention will involve delivering stimulation to both thighs in the few days after surgery, so that the investigators can assess whether this stimulation can preserve muscle mass and strength, and also, patients' ability to perform physical activities after surgery. In addition, the study will aim to find out whether any benefit provided by electrical stimulation can be increased further by taking a protein supplement at the same time.
Detailed description
The main objective of this trial is to assess whether neuromuscular stimulation (NMES) can minimise muscle loss following abdominal surgery for cancer; and whether such effect is further improved by simultaneous protein supplementation.
The main questions it aims to answer are:
- Does NMES training reduce the volume of muscle lost from the vastus lateralis (VL) muscle (in the thigh) after surgery as measured on ultrasound scan 5 days after surgery?
- Does NMES training together with protein supplementation lead to greater reduction of VL muscle volume loss on ultrasound 5 days after surgery then NMES alone?
Researchers will allocate participants into three groups (using a randomisation software).
All participants will visit the hospital once before surgery for starting point measurements including ultrasound.
Whilst they are in hospital, from the first until the fourth day after surgery, they will have the following interventions:
- Group 1 (the control group) will receive usual post-operative care with no additional interventions;
- Group 2 will receive normal postoperative care and twice daily NMES training sessions and a flavoured (placebo) drink
- Group 3 will receive normal post operative care as well as twice daily NMES training sessions and two protein rich drinks per day.
On the fifth day after surgery all participants will have repeat measurements including ultrasound to assess the extent of muscle loss they had since surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Control | No intervention | –Standard postoperative care days 1-4 |
| Group 2 - NMES (no protein drink) | Experimental | Device: Neuromuscular Electrical StimulationStandard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS placebo drink twice daily (no protein supplement) |
| Group 3 - NMES + protein drink | Experimental | Device: Neuromuscular Electrical Stimulation, Dietary Supplement: Protein supplement drinkStandard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS protein drink twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (age 18 or over at the time of diagnosis made at MDT (multi-disciplinary team meeting)
- MDT outcome of colorectal or gastric cancer or non-invasive neoplasia (tissue-proven, or radiologically diagnosed and clinically suspected) with the intention to treat with curative abdominal surgery
- Agreed management plan for open or minimally invasive (laparoscopic or robot assisted) segmental abdominal (colonic or gastric) resection at the Royal Derby Hospital
- Sufficient mobility and fitness to complete normal ERAS (enhanced recovery after surgery) protocols following surgery
- Basic conversational spoken English language
Key exclusion criteria (20 listed)
- Upper GI (gastrointestinal) cancer requiring thoracotomy/thoracoscopy
- Pre-existing neuromuscular disease (including Parkinsons disease)
- Pacemaker, implantable cardiac defibrillator or other implanted nerve stimulator device
- Metal prostheses or other metal-work in either upper legs (hip/knee/femur)
- Dementia or other cognitive problem or language barrier causing an inability to follow instructions and operate NMES machine
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 |
|---|---|---|
| Neuromuscular Electrical StimulationAlso: NMES, electrical stimulation, ES, electrical muscle stimulationNeuromuscular Electrical Stimulation training twice daily (30 minutes per session), during postoperative days 1-4. The training will be carried out using a handheld device. Training will be carried out by the participant themselves, with researcher supervision until independently able to do so. | Device | Group 2 - NMES (no protein drink), Group 3 - NMES + protein drink |
| Protein supplement drinkWhey protein isolate drink, to provide a total of 60 g protein per day (2 x30 g). The supplement will be provided in a powder form to participants. Participants will be asked to consume the supplement around the time of NMES training. | Dietary supplement | Group 3 - NMES + protein drink |
Primary outcome
Post-operative vastus lateralis (VL) muscle mass loss
Time frame: Pre-operatively and 5 days post-operatively
Vastus lateralis (VL) muscle mass loss as measured on ultrasound cross sectional area
12 secondary outcomes
Post-operative knee extensor strength losses
Time frame: Pre-operatively and 5 days post-operatively
Post-operative functional losses determined by short physical performance battery standardized physical function assessment tool
Time frame: Pre-operatively and 5 days post-operatively
Post-operative functional losses determined by Timed Up and Go standardized physical function assessment tool
Time frame: Pre-operatively and 5 days post-operatively
Post-operative functional losses determined by 6 minute walk test standardized physical function assessment tool
Time frame: Pre-operatively and 5 days post-operatively
Post-operative changes in muscle architecture as measured by pennation angle
Time frame: Pre-operatively and 5 days post-operatively
Post-operative changes in muscle architecture as measured by fascicle length
Time frame: Pre-operatively and 5 days post-operatively
Post-operative declines in neuromuscular function
Time frame: Pre-operatively and 5 days post-operatively
Post-operative loss of independence and quality of life
Time frame: Pre-operatively, 5 days post-operatively and 28 days post-operatively
Physical activity profiles of patients following major GI surgery
Time frame: Days 1-4 post operatively
Circulating amino acid profiles
Time frame: Pre-operatively, and on day 1 and 5 post-operatively
Systemic markers of inflammation
Time frame: Pre-operatively, and on day 1 and 5 post-operatively
Post-operative vastus lateralis (VL) muscle mass loss
Time frame: Pre-operatively and 5 days post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Beth Phillips, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation and Protein supplement drink in people with Surgery and Colorectal Cancer, run by University of Nottingham 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 20 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sawsan Abdul-Hamid, MBBS (00441332724687, sawsan.abdul-hamid@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative vastus lateralis (VL) muscle mass loss (time frame: Pre-operatively and 5 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.