Condition category
Signs and Symptoms
Date applied
19/05/2008
Date assigned
27/06/2008
Last edited
16/08/2010
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 Sara Booth

ORCID ID

Contact details

Palliative Care
Oncology Centre
Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OCRD2005/04

Study information

Scientific title

Acronym

Study hypothesis

The use of a handheld fan directed to the cheek does not relieve intractable breathlessness in patients with chronic maximally treated cardiac and respiratory disorders or advanced cancer.

Ethics approval

Ethics approval received from the Peterborough and Fenland Local Research Ethics Committee on the 6th September 2005 (ref: 05/Q0106/64).

Study design

Randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Breathlessness from malignant or non-malignant cause

Intervention

1. Use of handheld fan directed to the face (active treatment)
2. Use of handheld fan directed to the leg (control arm of study)

As per the protocol, the interventions of fan directed to face (active treatment) or to leg (control arm) were for 5 minutes each treatment. Washout periods were 10 minutes. There were no follow ups after the treatment and washout periods were completed as the study comprised a single intervention of treatments carried out in randomised order followed by washout after each treatment. The total carried out over a total duration of less than 1 hour.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Decrease in visual analogue scale of greater than 10 mm after use of handheld fan directed to face.

The primary outcome measure was a recording of visual analogue score for breathlessness. This was measured at baseline (time zero), after 5 minutes use of fan directed to face or leg, at completion of subsequent 10 minute washout period, after 5 minutes use of second treatment ( fan to face or leg) and after final 10 minute washout period.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

13/12/2005

Overall trial end date

18/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient is chronically breathless
2. Dyspnoea Exertion Scale (DES) levels 2 or above
3. Any diagnosis causing intractable breathlessness
4. Aged greater than 30 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

49

Participant exclusion criteria

1. Anaemic patients with haemoglobin (Hb) less than 10 g/l
2. Patients with fever greater than 38.0°C in last 24 hours
3. Patients on continuous oxygen
4. Patients requiring short burst oxygen therapy whilst completing the study
5. Patients with diseases or treatment affecting the trigeminal nerve supply
6. Patients on beta blockers
7. Patients with known autonomic neuropathy
8. Patients with peripheral vascular disease
9. Patients with cerebral disease or receiving cerebral radiotherapy
10. Patients with known severe cardiac or intrapulmonary arterio-venous shunts
11. Patients unable to understand or cooperate with study
12. Patients who do not wish to participate in the study
13. Patients whose disease is not maximally medically treated

Recruitment start date

13/12/2005

Recruitment end date

18/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Palliative Care, Oncology Centre, Box 193
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Trust R&D Department
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.addenbrookes.org.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK) - fans used in the study were donated and investigator time and equipment used was already available within the department

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20471544

Publication citations

  1. Results

    Galbraith S, Fagan P, Perkins P, Lynch A, Booth S, Does the use of a handheld fan improve chronic dyspnea? A randomized, controlled, crossover trial., J Pain Symptom Manage, 2010, 39, 5, 831-838, doi: 10.1016/j.jpainsymman.2009.09.024.

Additional files

Editorial Notes