Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial
OBJECTIVES:
Primary
- Determine whether acupuncture reduces pain and dysfunction in patients with head and
neck cancer who have undergone neck dissection.
Secondary
- 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.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
Pain, function and activities of daily living as measured by the Constant-Murley instrument
No
David G. Pfister, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
03-131
NCT00090337
November 2003
October 2007
Name | Location |
|---|---|
| Memorial Sloan - Kettering Cancer Center | New York, New York 10021 |
