Clinical trial NCT00090337: Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer
Official title: Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Pain
Keywords: 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
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage I lymphoepithelioma of the nasopharynx
stage I squamous cell carcinoma of the nasopharynx
stage II lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I lymphoepithelioma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II lymphoepithelioma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage I inverted papilloma of the paranasal sinus and nasal cavity
stage I midline lethal granuloma of the paranasal sinus and nasal cavity
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage II inverted papilloma of the paranasal sinus and nasal cavity
stage II midline lethal granuloma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-26
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Pain, function and activities of daily living as measured by the Constant-Murley instrument
Secondary outcomes:
measure: Xerostomia as measured by the Xerostomia Inventory questionnaire
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David G. Pfister, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.