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.

Condition	Intervention	Phase
Lung Cancer Surgery Pain	Device: Accupuncture	Phase III

Further Study Details: 

Primary Outcomes: - 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 and 90 days later
Expected Total Enrollment:  146

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 and 90 days later

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients undergoing unilateral thoracotomy at 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 INR >2.5 or 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 high or moderate risk of endocarditis as defined by the American Heart Association criteria (56) • 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00142532

Barrie Cassileth, Ph.D      212.639.8629    cassileth@mskcc.org

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Barrie Cassileth, PhD,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  04-073
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142532
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06