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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Study Groups

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Arm I

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

Group Type EXPERIMENTAL

acupuncture therapy

Intervention Type PROCEDURE

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

Arm II

Patients undergo standard of care for 4 weeks.

Group Type ACTIVE_COMPARATOR

standard follow-up care

Intervention Type PROCEDURE

Patients undergo standard care

Interventions

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acupuncture therapy

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

Intervention Type PROCEDURE

standard follow-up care

Patients undergo standard care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No