search
Back to results

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

Primary Purpose

Head and Neck Cancer, Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
acupuncture therapy
standard follow-up care
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan - Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.

Patients undergo standard of care for 4 weeks.

Outcomes

Primary Outcome Measures

Pain, function and activities of daily living as measured by the Constant-Murley instrument

Secondary Outcome Measures

Xerostomia as measured by the Xerostomia Inventory questionnaire

Full Information

First Posted
August 25, 2004
Last Updated
March 6, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00090337
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Allocation
Randomized
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients undergo standard of care for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
acupuncture therapy
Intervention Description
Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Intervention Description
Patients undergo standard care
Primary Outcome Measure Information:
Title
Pain, function and activities of daily living as measured by the Constant-Murley instrument
Secondary Outcome Measure Information:
Title
Xerostomia as measured by the Xerostomia Inventory questionnaire

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G. Pfister, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20406930
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs