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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer; Pain

Treatments: Procedure: acupuncture therapy; Procedure: standard follow-up care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00090337

P30CA008748 (U.S. NIH Grant/Contract)

MSKCC-03131A

03-131

R21CA098792 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Must have undergone neck dissection for cancer ≥ 3 months ago (in order to qualify pain as chronic sequella)
• Subjective complaint of pain and/or dysfunction in the neck and/or shoulders that, in the opinion of the investigator, is due to neck dissection
• Constant-Murley score ≤ 70 (i.e., moderate or severe pain and dysfunction)
• No moderate or severe neck or shoulder pain that, in the opinion of the investigator, is not due to cancer surgery

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 3 months since prior radiotherapy
• More than 6 weeks since prior acupuncture
• Concurrent analgesics allowed

Trial design

73 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.

Treatment:

Procedure: acupuncture therapy

Arm II

Active Comparator group

Description:

Patients undergo standard of care for 4 weeks.

Treatment:

Procedure: standard follow-up care