Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00090337
First received: August 25, 2004
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Pain |
Procedure: acupuncture therapy Procedure: standard follow-up care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Acupuncture
Acute Bronchitis
Benign Tumors
Cancer
Head and Neck Cancer
Tonsils and Adenoids
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Pain, function and activities of daily living as measured by the Constant-Murley instrument [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Xerostomia as measured by the Xerostomia Inventory questionnaire [ Designated as safety issue: No ]
| Estimated Enrollment: | 73 |
| Study Start Date: | November 2003 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090337
Locations
| United States, New York | |
| Memorial Sloan - Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | David G. Pfister, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | David G. Pfister, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00090337 History of Changes |
| Other Study ID Numbers: | 03-131, R21CA098792, P30CA008748, MSKCC-03131A |
| Study First Received: | August 25, 2004 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
pain recurrent squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage I squamous cell carcinoma of the larynx stage I verrucous carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage II verrucous carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx |
stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip stage I basal cell carcinoma of the lip stage II basal cell carcinoma of the lip stage III basal cell carcinoma of the lip stage IV basal cell carcinoma of the lip recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent verrucous carcinoma of the oral cavity stage I adenoid cystic carcinoma of the oral cavity |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013