Primary Lung Cancer or Secondary Lung MetastasesPhase 2NCT01123902
Effectiveness of a Hand-held Fan for Breathlessness
A Phase 2 study testing hand-held fan and wristband in people with Primary Lung Cancer or Secondary Lung Metastases and COPD III/IV, run by King's College London at 1 site in United Kingdom.
Trial summary
Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Lung Cancer or Secondary Lung Metastases, COPD III/IV
- What is being tested?
- hand-held fan and wristband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:
- Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)
- COPD stage III (severe) and IV (very severe) according to GOLD criteria.[7]
Who cannot join
- Unable to provide informed consent
- Too ill to be interviewed and not fluent or illiterate in German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness.
This phase II trial aims to determine the potential effectiveness of a hand-held fan to relieve breathlessness over time and to evaluate the recruitment into the study and the acceptance of the intervention and the control.
Read more
The intervention to be tested is a HHF directed to the area of the face innervated by the second and third trigeminal nerve branches. A wristband was chosen as control under the assumption that distraction could serve as a placebo.
The main outcomes for this study are uptake into the trial (proportion of patients from the longitudinal study participating in the RCT), adherence to the study, and use and acceptance of the intervention and the control. The main outcome for assessing the effect of the hand-held fan is change of severity of breathlessness between baseline and one month and two months, respectively.
- Being tested
- hand-held fan, wristband
- Keywords
- Breathlessness, Dyspnea, Hand-held fan, Palliative Care
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand-held fanDevice
Patients are instructed to direct the hand-held fan towards the face around the central part of the face, the sides of the nose and above the upper lip. The hand-held fan has three soft rotor blades and an unfoldable rotor unit.
wristbandDevice
Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.
| Study group | Role | What they receive |
|---|---|---|
| hand-held fan | Experimental | Not described Receives: Device: hand-held fan |
| wristband | Placebo comparator | Not described Receives: Device: wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of severity of breathlessness
Measured: between baseline and one month
Secondary outcomes (4)
use and acceptance of the intervention and the control
Measured: over 6 months
adherence to the study
Measured: 6 months
uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)
Measured: 18 months
change of severity of breathlessness
Measured: baseline and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJun 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Lung Cancer or Secondary Lung MetastasesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Investigators
- Claudia Bausewein, PhD MD MSc, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123902
- Sponsor's protocol ID
- CREC 05/06-69
- Status last verified
- Jul 2006
- First submitted
- 11 May 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bausewein C, Booth S, Gysels M, Kuhnbach R, Higginson IJ. Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial. BMC Palliat Care. 2010 Oct 19;9:22. doi: 10.1186/1472-684X-9-22.
PubMed 20958972
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
- ClinicalTrials.gov ID
- NCT01123902
- Acronym / sponsor ID
- CREC 05/06-69
- Keywords
- Breathlessness, Dyspnea, Hand-held fan, Palliative Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness.
This phase II trial aims to determine the potential effectiveness of a hand-held fan to relieve breathlessness over time and to evaluate the recruitment into the study and the acceptance of the intervention and the control.
The intervention to be tested is a HHF directed to the area of the face innervated by the second and third trigeminal nerve branches. A wristband was chosen as control under the assumption that distraction could serve as a placebo.
The main outcomes for this study are uptake into the trial (proportion of patients from the longitudinal study participating in the RCT), adherence to the study, and use and acceptance of the intervention and the control. The main outcome for assessing the effect of the hand-held fan is change of severity of breathlessness between baseline and one month and two months, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hand-held fan | Experimental | Device: hand-held fan |
| wristband | Placebo comparator | Device: wristband |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:
- Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)
- COPD stage III (severe) and IV (very severe) according to GOLD criteria.[7]
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Too ill to be interviewed and not fluent or illiterate in German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hand-held fanPatients are instructed to direct the hand-held fan towards the face around the central part of the face, the sides of the nose and above the upper lip. The hand-held fan has three soft rotor blades and an unfoldable rotor unit. | Device | hand-held fan |
| wristbandPatients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks. | Device | wristband |
Primary outcome
change of severity of breathlessness
Time frame: between baseline and one month
4 secondary outcomes
use and acceptance of the intervention and the control
Time frame: over 6 months
adherence to the study
Time frame: 6 months
uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)
Time frame: 18 months
change of severity of breathlessness
Time frame: baseline and two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
- Derived from this study: PubMed 20958972Bausewein C, Booth S, Gysels M, Kuhnbach R, Higginson IJ. Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial. BMC Palliat Care. 2010 Oct 19;9:22. doi: 10.1186/1472-684X-9-22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Bausewein, PhD MD MSc principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hand-held fan and wristband in people with Primary Lung Cancer or Secondary Lung Metastases and COPD III/IV, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of severity of breathlessness (time frame: between baseline and one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01123902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2010.