Clinical trial NCT00142532: Acupuncture for Post-Thoracotomy Pain
Official title: Acupuncture for Post-Thoracotomy Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Pain
Keywords: Acupuncture
Pain
Lung Cancer
Thoracotomy
Surgery
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain after surgery for lung cancer (thoracotomy) may persist for years and require long-term analgesic use. Prior studies have shown that acupuncture reduces pain and medication use in the early post-operative period after abdominal surgery, suggesting that acupuncture may have a role in preventing chronic post-thoracotomy pain. This study is being done in order to determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use
timeFrame: one year
measure: To determine whether acupuncture affects the immediate post-operative period and/or 30, 60, 90 days and approximately 12 months later
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Barrie Cassileth, PhD
role: PRINCIPAL_INVESTIGATOR
References: