Is NeuroMuscular Electrical Stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy?

ISRCTN	ISRCTN42944026
DOI	https://doi.org/10.1186/ISRCTN42944026
ClinicalTrials.gov number	NCT01097317
Secondary identifying numbers	1.0

Submission date: 06/11/2008
Registration date: 11/12/2008
Last edited: 27/07/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/trial-neuromuscular-electrical-stimulation-nmes-non-small-cell-lung-cancer

Contact information

Miss Helen Phillips
Scientific

Wales Cancer Trials Unit
School of Medicine
Cardiff University
6th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Phone	+44 (0)29 2068 7461
Email	helen.phillips@wctu.wales.nhs.uk

Study information

Study design	Open randomised controlled phase II trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	NMES
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 patients 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.
Ethics approval(s)	Nottingham 1 REC on 21/04/2009 (ref: 9/H0403/24)
Condition	Non-small cell lung cancer
Intervention	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
Intervention type	Other
Primary outcome measure	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 measures	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).
Overall study start date	01/02/2009
Overall study end date	01/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	52
Total final enrolment	49
Participant 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
Participant exclusion criteria	1. Implanted cardiac pacemaker 2. Epilepsy 3. Spinal cord pathology 4. Pregnancy
Recruitment start date	01/02/2009
Recruitment end date	01/02/2012

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Wales Cancer Trials Unit

Cardiff
CF14 4YS
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

Research and Commercial Division (RACD)
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Phone	+44 (0)29 2087 5834
Email	shawc3@cardiff.ac.uk
Website	http://www.cardiff.ac.uk
"ROR"	https://ror.org/03kk7td41

Funders

Funder type

Other

National Cancer Research Institute (NCRI) Supportive and Palliative Care (SuPaC) Research Collaboration (UK) (ref: LCSuPaC 35)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/12/2013		Yes	No
Plain English results			27/07/2022	No	Yes

Editorial Notes

27/07/2022: Cancer Research UK plain English results summary link and total final enrolment added.