Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial
N/A
N/A
Both
Head and Neck Cancer, Pain
Trial Information
Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Pain, function and activities of daily living as measured by the Constant-Murley instrument
Safety Issue:
No
Principal Investigator
David G. Pfister, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
03-131
NCT ID:
NCT00090337
Start Date:
November 2003
Completion Date:
October 2007
Related Keywords:
- Head and Neck Cancer
- 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
- 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
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Memorial Sloan - Kettering Cancer Center | New York, New York 10021 |
