Pain Clinical Trial
Official title:
Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial
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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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