Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer

Phase 3

Completed

• Conditions: Head and Neck Cancer; Pain
• Interventions: Procedure: standard follow-up care; Procedure: acupuncture therapy

• Registration Number: NCT00090337
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-25
• Study First Posted: 2004-08-26
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm II	standard follow-up care	Patients undergo standard of care for 4 weeks.
Arm I	acupuncture therapy	Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Pain, function and activities of daily living as measured by the Constant-Murley instrument

Secondary Outcome Measures

Name	Time	Method
Xerostomia as measured by the Xerostomia Inventory questionnaire

Trial Locations

Locations (1)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States