Postoperative NMES on both thighs with protein during abdominal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants who have colorectal or gastric cancer and are undergoing curative abdominal surgery are assigned to three groups: usual post-op care, usual care plus twice-daily NMES on both thighs with a placebo drink, or usual care plus twice-daily NMES plus two protein drinks daily. Ultrasound measurements of the vastus lateralis are taken before surgery and on day five to assess muscle loss. The trial aims to see if NMES reduces muscle loss after surgery and whether protein supplementation provides additional benefit. The study is conducted at Royal Derby Hospital with University of Nottingham as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• Royal Derby Hospital
  Derby, Derbyshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Sawsan Abdul-Hamid, MBBS
• Email: sawsan.abdul-hamid@nottingham.ac.uk
• Phone: 00441332724687

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.