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New treatment option for Surgery
Official title Postoperative Electrical Muscle Stimulation Two
ClinicalTrials.gov ID: NCT06964438
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Agreed management plan for open or minimally invasive (laparoscopic or robot assisted) segmental abdominal (colonic or gastric) resection at the...
- Sufficient mobility and fitness to complete normal ERAS (enhanced recovery after surgery) protocols following surgery
- Basic conversational spoken English language
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Derby, Derbyshire, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Derby, Derbyshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.