ISRCTN ISRCTN89462491
DOI https://doi.org/10.1186/ISRCTN89462491
ClinicalTrials.gov (NCT) NCT00067691
Protocol serial number N/A
Sponsor National Center for Complementary and Alternative Medicine (NCCAM) (USA)
Funder National Center for Complementary and Alternative Medicine (NCCAM) (USA)
Submission date
20/04/2005
Registration date
27/04/2005
Last edited
10/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marc Feinstein
Scientific

1275 York Avenue
New York
10021
United States of America

Email feinstem@mskcc.org

Study information

Primary study designInterventional
Study designRandomised placebo controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesThe purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients
Ethics approval(s)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.
Health condition(s) or problem(s) studiedShortness of breath in cancer patients
InterventionAcupuncture versus placebo.
Intervention typeOther
Primary outcome measure(s)

Subjective sensation of breathlessness.

Key secondary outcome measure(s)

Change in medication use.

Completion date30/11/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2001
Date of final enrolment30/11/2003

Locations

Countries of recruitment

  • United States of America

Study participating centre

1275 York Avenue
New York
10021
United States of America

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 18/08/2005 Yes No