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Acupuncture for Post-Thoracotomy Pain: A Randomized Controlled Trial


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Pain

Thank you

Trial Information

Acupuncture for Post-Thoracotomy Pain: A Randomized Controlled Trial


Rationale:

Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In
recent years, researchers have come to understand how acupuncture might work in terms of
nerve stimulation and the release of chemical messages in the body. Researchers have found
evidence that acupuncture is useful in treating a variety of conditions, including headache,
nausea, and pain after surgery.

Pain is a common problem after surgery for lung cancer. Many patients experience pain in the
first few days after surgery, despite medication. In some patients, this pain can last for
many months or years afterwards.

Purpose:

A pilot study of acupuncture in patients undergoing lung cancer surgery was conducted
previously and found that this study was feasible to implement and well-received by
patients. We now wish to conduct a larger study in order to determine the effects of
acupuncture on pain in patients undergoing surgery for lung cancer.

- To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces
pain or analgesic use

- To determine whether acupuncture affects the immediate post-operative period and/or 30,
60,90 days and approximately 12 months later.


Inclusion Criteria:



- Patients undergoing unilateral thoracotomy at Memorial Sloan-Kettering Cancer Center
(MSKCC)

- Age greater than or equal to 18 years old.

Exclusion Criteria:

- Any of the following procedures: hemiclamshell, clamshell, extrapleural approach,
chest wall involvement, esophagectomy. These more extensive procedures have a higher
risk of complications.

- Acupuncture treatment in the previous six weeks, to discount any persisting effect of
acupuncture

- Platelets < 20,000 or International Normalized Ratio (INR) > 2.5 or absolute
neutrophil count (ANC) < 0.5; though it would be unusual for any patient to be
operated on with such values, it seems wise as a precautionary measure to avoid risk
of bleeding from acupuncture.

- Known cardiac conditions constituting a high or moderate risk of endocarditis as
defined by the American Heart Association criteria

- Patients unable to remove studs without assistance, who have no home assistance, and
who are unable or unwilling to return to the hospital in the event that they decide
to remove studs before the post-discharge visit.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Barrie Cassileth, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-073

NCT ID:

NCT00142532

Start Date:

June 2005

Completion Date:

January 2008

Related Keywords:

  • Lung Cancer
  • Pain
  • Acupuncture
  • Pain
  • Lung Cancer
  • Thoracotomy
  • Surgery
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021