Condition category
Signs and Symptoms
Date applied
20/04/2005
Date assigned
27/04/2005
Last edited
10/08/2009
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 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

  1. 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.

Additional files

Editorial Notes