Contact information
Type
Scientific
Primary contact
Dr Marc Feinstein
ORCID ID
Contact details
1275 York Avenue
New York
10021
United States of America
feinstem@mskcc.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00067691
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients
Ethics approval
The study was approved by the institutional review board at Memorial Sloan-Kettering Cancer Center (MSKCC) in accordance with an assurance filed with and approved by the Department of Health and Human Services.
Study design
Randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Shortness of breath in cancer patients
Intervention
Acupuncture versus placebo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Subjective sensation of breathlessness.
Secondary outcome measures
Change in medication use.
Overall trial start date
01/11/2001
Overall trial end date
30/11/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of local or metastatic breast or lung cancer
2. Shortness of breath with onset after cancer diagnosis
3. Life expectancy of at least 4 weeks
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
1. Prior acupuncture
2. Other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity
3. No chest wall deformity
4. Neuromuscular disorders
5. Pulmonary vascular disease
6. Anaemia
7. Uncontrolled pain or infection
8. Heart valve dysfunction
Recruitment start date
01/11/2001
Recruitment end date
30/11/2003
Locations
Countries of recruitment
United States of America
Trial participating centre
1275 York Avenue
New York
10021
United States of America
Sponsor information
Organisation
National Center for Complementary and Alternative Medicine (NCCAM) (USA)
Sponsor details
National Institutes of Health
Maryland
Bethesda
20892
United States of America
info@nccam.nih.gov
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Center for Complementary and Alternative Medicine (NCCAM) (USA)
Alternative name(s)
NCCAM
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/16109163
Publication citations
-
Results
Vickers AJ, Feinstein MB, Deng GE, Cassileth BR, Acupuncture for dyspnea in advanced cancer: a randomized, placebo-controlled pilot trial [ISRCTN89462491]., BMC Palliat Care, 2005, 4, 5, doi: 10.1186/1472-684X-4-5.