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

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00090337

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 III

MedlinePlus related topics: Acupuncture Cancer Head and Neck Cancer Salivary Gland Disorders Surgery Tonsils and Adenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial

Further study details as provided by National Cancer Institute (NCI):

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
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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
Arm II: Active Comparator 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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

David G. Pfister, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( David G. Pfister )
Study ID Numbers:	CDR0000479631, MSKCC-03131A
Study First Received:	August 25, 2004
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00090337 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

pain
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

Study placed in the following topic categories:

Nasopharyngeal Carcinoma
Laryngeal Carcinoma
Carcinoma, Basal Cell
Pain
Granuloma
Squamous Cell Carcinoma
Recurrence
Hypopharyngeal Cancer
Carcinoma

Metastatic Squamous Neck Cancer With Occult Primary
Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Epidermoid Carcinoma
Adenoid Cystic Carcinoma
Carcinoma, Squamous Cell
Papilloma
Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009