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

March 6, 2013 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan - Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
Procedure: acupuncture therapy
Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks
Active Comparator: Arm II
Patients undergo standard of care for 4 weeks.
Procedure: standard follow-up care
Patients undergo standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain, function and activities of daily living as measured by the Constant-Murley instrument

Secondary Outcome Measures

Outcome Measure
Xerostomia as measured by the Xerostomia Inventory questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David G. Pfister, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

August 25, 2004

First Submitted That Met QC Criteria

August 25, 2004

First Posted (Estimate)

August 26, 2004

Study Record Updates

Last Update Posted (Estimate)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-131
  • P30CA008748 (U.S. NIH Grant/Contract)
  • R21CA098792 (U.S. NIH Grant/Contract)
  • MSKCC-03131A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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