title: Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study.
abstract: BACKGROUND
  A reduced exercise capacity is associated with increased morbidity and mortality in patients with advanced non-small cell lung cancer (NSCLC). Therapeutic exercise can be beneficial and neuromuscular electrical stimulation (NMES) of the quadriceps muscles may represent a practical approach. The primary aim of this study was to determine the acceptability of NMES of the quadriceps to patients with NSCLC used alongside palliative chemotherapy. Secondary aims explored aspects of safety and efficacy of NMES in this setting.
  
  
  METHODS
  Patients with advanced NSCLC due to receive first-line palliative chemotherapy were randomized to usual care with or without NMES. They were asked to undertake 30 minute sessions of NMES, ideally daily, but as a minimum, three times weekly. For NMES to be considered acceptable, it was predetermined that ≥80% of patients should achieve this minimum level of adherence. Qualitative interviews were held with a subset of patients to explore factors influencing adherence. Safety was assessed according to the Common Terminology Criteria for Adverse Events. Quadriceps muscle strength, thigh lean mass, and physical activity level were assessed at baseline and after three cycles of chemotherapy.
  
  
  RESULTS
  49 patients (28 male, median (IQR) age 69 (64-75) years) participated. Of 30 randomized to NMES, 18 were eligible for the primary endpoint, of whom 9 (50% [90% CI, 29 to 71]) met the minimum level of adherence. Adherence was enhanced by incorporating sessions into a daily routine and hindered by undesirable effects of chemotherapy. There were no serious adverse events related to NMES, nor significant differences in quadriceps muscle strength, thigh lean mass or physical activity level between groups.
  
  
  CONCLUSIONS
  NMES is not acceptable in this setting, nor was there a suggestion of benefit. The need remains to explore NMES in patients with cancer in other settings.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN 42944026 www.controlled-trials.com/ISRCTN42944026.
authors.affiliation: Kings College London, Cicely Saunders Institute, Department of Palliative Care, Policy & Rehabilitation, London, United Kingdom ; Department of Palliative Medicine, Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
authors.forename: Matthew
authors.initials: M
authors.lastname: Maddocks
authors.affiliation: School of Biosciences, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Halliday
authors.affiliation: King's Mill Hospital, Sherwood Forest Hospitals National Health Service Foundation Trust, Sutton in Ashfield, United Kingdom.
authors.forename: Alpna
authors.initials: A
authors.lastname: Chauhan
authors.affiliation: Department of Palliative Medicine, Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
authors.forename: Victoria
authors.initials: V
authors.lastname: Taylor
authors.affiliation: Marie Curie Research Centre and Wales Cancer Trials Unit, Cardiff University, Cardiff, United Kingdom.
authors.forename: Annmarie
authors.initials: A
authors.lastname: Nelson
authors.affiliation: Marie Curie Research Centre and Wales Cancer Trials Unit, Cardiff University, Cardiff, United Kingdom.
authors.forename: Cathy
authors.initials: C
authors.lastname: Sampson
authors.affiliation: Marie Curie Research Centre and Wales Cancer Trials Unit, Cardiff University, Cardiff, United Kingdom.
authors.forename: Anthony
authors.initials: A
authors.lastname: Byrne
authors.affiliation: Marie Curie Research Centre and Wales Cancer Trials Unit, Cardiff University, Cardiff, United Kingdom.
authors.forename: Gareth
authors.initials: G
authors.lastname: Griffiths
authors.affiliation: Department of Palliative Medicine, Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.
authors.forename: Andrew
authors.initials: A
authors.lastname: Wilcock
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000503:physiopathology / Q000628:therapy*; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000503:physiopathology*; D010166:Palliative Care
chemical_list: D000305:Adrenal Cortex Hormones; D018931:Antineoplastic Agents, Hormonal