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Is NeuroMuscular Electrical Stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy?
ISRCTN ISRCTN42944026
DOI 10.1186/ISRCTN42944026
ClinicalTrials.gov identifier NCT01097317
EudraCT number
Public title Is NeuroMuscular Electrical Stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy?
Scientific title Is NeuroMuscular Electrical Stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy?: an open randomised phase II trial
Acronym NMES
Serial number at source 1.0
Study hypothesis Primary: Is NMES an acceptable supportive therapy for patients with non-small cell lung cancer undergoing at least 3 cycles of palliative chemotherapy?
Secondary:
i) Is NMES a safe intervention to offer patients undergoing palliative chemotherapy?
ii) To what extent does 3 cycles of palliative chemotherapy impact on leg muscle strength, body composition and physical activity levels in patients with NSCLC and can the use of NMES influence these changes?
iii) What is the rate of recovery or decline in these parameters following cessation of 3-4 cycles of chemotherapy and can the use of NMES influence this?
iv) What are patientsí attitudes about the use of NMES during chemotherapy?

As of 24/02/2011 the anticipated end date for this trial has been updated from 01/02/2011 to 01/02/2012.
Lay summary http://www.cancerhelp.org.uk/trials/trial-neuromuscular-electrical-stimulation-nmes-non-small-cell-lung-cancer
Ethics approval Nottingham 1 REC on 21/04/2009 (ref: 9/H0403/24)
Study design Open randomised controlled phase II trial
Countries of recruitment United Kingdom
Disease/condition/study domain Non-small cell lung cancer
Participants - inclusion criteria 1. Both males and females, 16 years or over
2. Informed consent
3. Histological diagnosis of NSCLC
4. Eastern Collaborative Oncology Group (ECOG) Performance Status of 0, 1 or 2
5. Scheduled to receive 3-4 cycles of first line palliative chemotherapy with carboplatin/vinorelbine
Participants - exclusion criteria 1. Implanted cardiac pacemaker
2. Epilepsy
3. Spinal cord pathology
4. Pregnancy
Anticipated start date 01/02/2009
Anticipated end date 01/02/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 52
Interventions Participants will be randomly allocated (1:1 allocation ratio) to receive one of the following treatment regimen(s):

Control arm: Three to four cycles of first line palliative chemotherapy with carboplatin/vinorelbine administered as part of usual care by Nottingham University Hospital NHS Trust staff. Each chemotherapy cycle is planned to last for 21 days and consists of an administration of vinorelbine and carboplatin (day 1 of cycle) and a second administration of vinorelbine one week later (day 8 of cycle).

Intervention arm:
The palliative chemotherapy described above plus NMES.

NMES programme:
NMES for 30 min daily at home to the anterior thighs throughout chemotherapy. Because patients are generally anxious about starting chemotherapy we will defer initiating NMES until one week after commencing cycle one. A physiotherapist will supervise the first session of NMES either at hospital or in the patient's home depending on patient preference. This will be supplemented by written instructions, weekly phone calls and home visits if required. Stimulation will be delivered using a MicroStim Exercise Stimulator MS2v2 (Odstock Medical Ltd, UK) and self-adhesive electrodes placed over the body of the quadriceps. The intensity or amplitude (device output 0-120 mA, tested across 1,000 ohm) will initially be set to elicit a visible and comfortable muscle contraction. Thereafter, patients will be encouraged to increase the amplitude as tolerated during the monitoring phone calls. The proportion of the treatment duration which is active, i.e. the stimulation is on, will increase on a weekly basis from 11% to 18% to 25%, remaining constant thereafter.

Contact details of Principal Investigator:
Dr Andrew Wilcock
Hayward House Macmillan Specialist Palliative Cancer Care Unit
Nottingham University Hospitals NHS Trust
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Email: andrew.wilcock@nottingham.ac.uk
Primary outcome measure(s) Adherence to NMES: Proportion of patients completing a pre-determined level of compliance to the recommended NMES programme (NMES for 30 min three times a week) measured using a self-report daily diary.

The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).
Secondary outcome measure(s) 1. Safety of NMES: real-time adverse event reporting using the Common Terminology Criteria for Adverse Events (CTC AE) v3.0
2. Quadriceps muscle strength: peak torque (Nm) measured using a portable Manual Muscle Tester® dynamometer (Lafayette Instruments, USA)
3. Body composition: lean tissue mass of the body and thighs (kg) assessed by low-dose dual energy x-ray absorptiometry (DEXA)
4. Physical activity level: mean daily step count assessed by a small, lightweight activPAL™ accelerometer worn on the thigh for one week
5. Response to chemotherapy: overall objective clinical response categorised using Response Evaluation Criteria In Solid Tumours, documented from patients' medical reports
6. Nutritional intake: mean daily energy (kJ/d) and protein (g/d) intake estimated from a 3-day food and drink diary
7. Fatigue: Multidimensional Fatigue Inventory
8. Quality of life: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) and the lung cancer specific module EORTC QLQ-LC13

The primary and secondary outcomes will be assessed at baseline, end of treatment at week 9 or 12 (depending on 3 or 4 chemotherapy cycles), follow-up assessments at week 17 or 20 (depending on 3 or 4 chemotherapy cycles).
Sources of funding National Cancer Research Institute (NCRI) Supportive and Palliative Care (SuPaC) Research Collaboration (UK) (ref: LCSuPaC 35)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24386491
Contact name Miss  Helen  Phillips
  Address Wales Cancer Trials Unit
School of Medicine
Cardiff University
6th Floor, Neuadd Meirionnydd
Heath Park
  City/town Cardiff
  Zip/Postcode CF14 4YS
  Country United Kingdom
  Tel +44 (0)29 2068 7461
  Fax +44 (0)29 2068 7501
  Email helen.phillips@wctu.wales.nhs.uk
Sponsor Cardiff University (UK)
  Address Research and Commercial Division (RACD)
7th Floor
30-36 Newport Road
  City/town Cardiff
  Zip/Postcode CF24 0DE
  Country United Kingdom
  Tel +44 (0)29 2087 5834
  Email shawc3@cardiff.ac.uk
  Sponsor website: http://www.cardiff.ac.uk
Date applied 06/11/2008
Last edited 09/01/2014
Date ISRCTN assigned 11/12/2008
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