Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00090337|
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : March 7, 2013
RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is not yet known whether acupuncture is more effective than standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.
PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared to standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Pain||Procedure: acupuncture therapy Procedure: standard follow-up care||Phase 3|
- Determine whether acupuncture reduces pain and dysfunction in patients with head and neck cancer who have undergone neck dissection.
- Determine whether acupuncture relieves dry mouth in these patients.
OUTLINE: This is a randomized, controlled study. Patients are stratified according to surgical procedure (selective neck dissection vs modified radical neck dissection vs radical neck dissection) and baseline Constant-Murley score (≤ 35 vs > 35). Patients are randomized into 1 of 2 treatment arms.
- Arm I: Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
- Arm II: Patients undergo standard of care for 4 weeks. In both arms, treatment continues in the absence of unacceptable toxicity.
The Constant-Murley score is assessed at baseline and then at week 6. Pain medication use is recorded at baseline, during study treatment, and then at week 6. Numerical Rating Scale of pain on activity and xerostomia inventories are completed at baseline and then at weeks 5 and 6.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||73 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Experimental: Arm I
Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
Procedure: acupuncture therapy
Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks
Active Comparator: Arm II
Patients undergo standard of care for 4 weeks.
Procedure: standard follow-up care
Patients undergo standard care
- Pain, function and activities of daily living as measured by the Constant-Murley instrument
- Xerostomia as measured by the Xerostomia Inventory questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090337
|United States, New York|
|Memorial Sloan - Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||David G. Pfister, MD||Memorial Sloan Kettering Cancer Center|