NCT00090337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at below P25 for phase_3 head-and-neck-cancer

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

3.9 years

First QC Date

August 25, 2004

Last Update Submit

March 6, 2013

Conditions

Head and Neck CancerPain

Keywords

painrecurrent squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the lipstage I basal cell carcinoma of the lipstage II basal cell carcinoma of the lipstage III basal cell carcinoma of the lipstage IV basal cell carcinoma of the liprecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage I adenoid cystic carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I verrucous carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavitymetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage I lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent salivary gland cancerstage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Xerostomia as measured by the Xerostomia Inventory questionnaire

Study Arms (2)

Arm I

EXPERIMENTAL

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

Procedure: acupuncture therapy

Arm II

ACTIVE COMPARATOR

Patients undergo standard of care for 4 weeks.

Procedure: standard follow-up care

Interventions

acupuncture therapyPROCEDURE

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

Arm I
standard follow-up carePROCEDURE

Patients undergo standard care

Arm II

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • 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.

    PMID: 20406930RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsPainSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • David G. Pfister, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2004

First Posted

August 26, 2004

Study Start

November 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(1)