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

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ClinicalTrials.gov Identifier: NCT00090337
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : March 7, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

August 25, 2004
August 26, 2004
March 7, 2013
November 2003
October 2007   (Final data collection date for primary outcome measure)
Pain, function and activities of daily living as measured by the Constant-Murley instrument
Not Provided
Complete list of historical versions of study NCT00090337 on ClinicalTrials.gov Archive Site
Xerostomia as measured by the Xerostomia Inventory questionnaire
Not Provided
Not Provided
Not Provided
 
Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer
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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Supportive Care
  • Head and Neck Cancer
  • Pain
  • Procedure: acupuncture therapy
    Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks
  • Procedure: standard follow-up care
    Patients undergo standard care
  • Experimental: Arm I
    Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
    Intervention: Procedure: acupuncture therapy
  • Active Comparator: Arm II
    Patients undergo standard of care for 4 weeks.
    Intervention: Procedure: standard follow-up care
Pfister DG, Cassileth BR, Deng GE, Yeung KS, Lee JS, Garrity D, Cronin A, Lee N, Kraus D, Shaha AR, Shah J, Vickers AJ. Acupuncture for pain and dysfunction after neck dissection: results of a randomized controlled trial. J Clin Oncol. 2010 May 20;28(15):2565-70. doi: 10.1200/JCO.2009.26.9860. Epub 2010 Apr 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
60
October 2007
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00090337
03-131
R21CA098792 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-03131A
Not Provided
Not Provided
Not Provided
David G. Pfister, Memorial Sloan-Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: David G. Pfister, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP