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

Abstract

Background Colorectal cancer is associated with secondary sarcopenia (muscle loss) and myosteatosis (fatty infiltration of muscle) and patients who exhibit these host characteristics have poorer outcomes following surgery. Furthermore, patients, who undergo curative advanced rectal cancer surgery such as pelvic exenteration, are at risk of skeletal muscle loss due to immobility, malnutrition and a post-surgical catabolic state. Neuromuscular electrical stimulation (NMES) may be a feasible adjunctive treatment to help ameliorate these adverse side-effects. Hence, the purpose of this study is to investigate NMES as an adjunctive pre- and post-operative treatment for rectal cancer patients in the radical pelvic surgery setting and to provide early indicative evidence of efficacy in relation to key health outcomes. Method In a phase II, double-blind, randomised controlled study, 58 patients will be recruited and randomised (1:1) to either a treatment (NMES plus standard care) or placebo (sham-NMES plus standard care) group. The intervention will begin 2 weeks pre-operatively and continue for 8 weeks after exenterative surgery. The primary outcome will be change in mean skeletal muscle attenuation, a surrogate marker of myosteatosis. Sarcopenia, quality of life, inflammatory status and cancer specific outcomes will also be assessed. Discussion This phase II randomised controlled trial will provide important preliminary evidence of the potential for this adjunctive treatment. It will provide guidance on subsequent development of phase 3 studies on the clinical benefit of NMES for rectal cancer patients in the radical pelvic surgery setting. Trial registration Protocol version 6.0; 05/06/20. ClinicalTrials.gov NCT04065984. Registered on 22 August 2019; recruiting.

Efficacy of neuromuscular electrical stimulation for thoracic and abdominal surgery: A systematic review and meta-analysis

“…The 18 RCTs included 915 patients who underwent thoracic and abdominal surgeries and were postoperatively treated with NMES. Out of the 18 RCTs, four [ 33 , 36 , 41 , 44 ] were only protocol registrations and did not have outcome data.…”

“…The length of the intervention spanned 5 days to 4 weeks, and the frequency of the intervention ranged from three times per week to every day. Seven studies involved stimulation of one muscle [ 30 , 31 , 35 , 39 , 43 , 45 , 46 ], nine involved stimulations of multiple muscles [ 32 – 34 , 36 – 38 , 41 , 42 , 44 ], one involved stimulation of the common peroneal nerve [ 47 ], and one involved stimulation of the lower limb [ 41 ]. The most common stimulation site was the quadriceps.…”

“…After screening, we excluded 17 studies due to incorrect population, nine for incorrect intervention, and one for incorrect design (S2 Table ). In the qualitative synthesis, we identified 18 RCTs [30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47] that met all the eligibility criteria (Fig 1 and Table 1). The 18 RCTs included 915 patients who underwent thoracic and abdominal surgeries and were postoperatively treated with NMES.…”

“…Out of the 18 RCTs, four [33,36,41,44] were only protocol registrations and did not have outcome data. Overall, there were 10 studies [30][31][32][33][34][35][36][37][38][39] in cardiovascular surgery, two [40,41] in pulmonary surgery, five [42][43][44][45][46] in digestive system surgery, and one [47] in other surgeries.…”

“…Out of the 18 RCTs, four [33,36,41,44] were only protocol registrations and did not have outcome data. Overall, there were 10 studies [30][31][32][33][34][35][36][37][38][39] in cardiovascular surgery, two [40,41] in pulmonary surgery, five [42][43][44][45][46] in digestive system surgery, and one [47] in other surgeries. Cardiovascular surgery studies included aortic valve replacement, coronary artery bypass grafting, heart transplantation, mitral valve replacement, mitral valve reconstruction, or tricuspid valve reconstruction.…”