Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vincent Crosby

ORCID ID

Contact details

Hospital Palliative Care Team
E Floor East Block
University Hospital NHS Trust
Nottingham
NG7 2UH
United Kingdom
+44
matthew.maddocks@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192170447

Study information

Scientific title

Acronym

Study hypothesis

Does neuromuscular electrical stimulation (NMES) of the thigh muscles of people with lung cancer improve muscle endurance, exercise endurance and physical activity levels as assessed by exercise on a Cybex machine, the endurance shuttle walking test (ESWT) and an ActivPal monitor respectively?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cancer: Lung

Intervention

A pilot study. Block randomisation to one of two groups.
Group 1: 4 weeks with NMES device
Group 2:- 4 weeks without device followed by 4 weeks with device

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/11/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

16 people with non-small cell cancer and an East Oncology Group (EOG) performance status of 0 to 1 and who have lost less than 10% of their normal body weight.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

16

Participant exclusion criteria

1. Pain or pathology limiting walking ability for the shuttle walking tests or limiting leg exercise on the cybex machine
2. History of ischaemic heart disease
3. Radiotherapy or chemotherapy in the previous 4 weeks as this may increase fatigue
4. Presence of a pacemaker - because the NMES device delivers a small electrical current, it is possible that this will interfere with the functioning of the pacemaker

Recruitment start date

02/11/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hospital Palliative Care Team
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Queen's Medical Centre University Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nottingham Healthcare Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19748761

Publication citations

  1. Results

    Maddocks M, Lewis M, Chauhan A, Manderson C, Hocknell J, Wilcock A, Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer., J Pain Symptom Manage, 2009, 38, 6, 950-956, doi: 10.1016/j.jpainsymman.2009.05.011.

Additional files

Editorial Notes