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Effectiveness of a Hand-held Fan for Breathlessness

This study has been completed.
Sponsor:
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT01123902
First received: May 11, 2010
Last updated: May 13, 2010
Last verified: July 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Primary Lung Cancer or Secondary Lung Metastases
COPD III/IV
 Device: hand-held fan
Device: wristband
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King's College London:

Primary Outcome Measures:
  • change of severity of breathlessness [ Time Frame: between baseline and one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • use and acceptance of the intervention and the control [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
  • adherence to the study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • uptake into the trial (proportion of patients from the longitudinal study participating in the RCT) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • change of severity of breathlessness [ Time Frame: baseline and two months ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hand-held fan Device: hand-held fan
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.
Placebo Comparator: wristband Device: wristband
Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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]

Exclusion Criteria:

  • Unable to provide informed consent
  • Too ill to be interviewed and not fluent or illiterate in German
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123902

Locations
United Kingdom
King's College London
London, United Kingdom, SE5 9PJ
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Claudia Bausewein, PhD MD MSc King's College London
  More Information

No publications provided

Responsible Party: Prof Irene Higginson, King's College London
ClinicalTrials.gov Identifier: NCT01123902     History of Changes
Other Study ID Numbers: CREC 05/06-69
Study First Received: May 11, 2010
Last Updated: May 13, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by King's College London:
Breathlessness
Dyspnea
Hand-held fan
Palliative Care

Additional relevant MeSH terms:
Dyspnea
Lung Neoplasms
Neoplasm Metastasis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013