A Pilot Study of Acupuncture Treatment for Dysphagia - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):	Weidong Lu, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00797732

Purpose

This study is a pilot randomized, sham-controlled trial of acupuncture for Head and Neck Cancer patients with dysphagia after chemoradiation therapy. The study will assess the feasibility of recruiting and retaining head and neck cancer patients, will assess the feasibility of administering the acupuncture protocol as well as a series of outcome instruments and protocols, and will collect preliminary data on the efficacy and safety of acupuncture on dysphagia related symptoms and health related quality of life.

Condition	Intervention
Carcinomas, Squamous Cell Dysphagia	Device: Acupuncture

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Cancer Head and Neck Cancer Swallowing Disorders

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

MDADI will be measured at baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks post CRT and 6 months follow up (12 mo from baseline). [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks post CRT, and 6 months followup ( 12 mo from baseline) ] [ Designated as safety issue: Yes ]
M.D. Anderson Dysphagia Inventory (MDADI) is used for the primary outcome measure.

Secondary Outcome Measures:

Other QOL, salivary flow rates and cytokines measures [ Time Frame: baseline, last session of acupuncture ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Acupuncture	Device: Acupuncture active acupuncture (n=21) or sham acupuncture (n=21), once every 2 weeks for 24 weeks.
Sham Comparator: Sham Acupuncture	Device: Acupuncture active acupuncture (n=21) or sham acupuncture (n=21), once every 2 weeks for 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) at stage II, III and IV, without evidence of distant metastasis. Stage I disease will also be permitted if the patient is receiving CRT;
Primary tumor sites eligible: nasopharyngeal, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary squamous cell carcinoma (SCC) in the neck will also be eligible. SCC of the oral cavity will also be eligible with the approval of the treating staff;
Receiving chemoradiation;
Currently or recently undergoing swallowing therapy program with or without feeding tube use, with or without neck dissection;
Age ≥ 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Adequate hematological function: neutrophil count >1.0 x109/L, platelet count >50x109/L
Signed informed consent.

Exclusion Criteria

Patients with the following criteria will NOT be eligible for the study:

Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
Wearing a pacemaker or implantable cardioverter-defibrillator;
History of significant neurologic disorder that affects swallowing, including stroke, neurodegenerative disease, advanced dementia, or uncontrolled seizure disorder;
Active clinically significant uncontrolled infection;
Prior use of acupuncture for dysphagia;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797732

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Weidong Lu, MB, MPH, PhD

Harvard Medical School/Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Weidong Lu, Instructor in Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00797732 History of Changes
Other Study ID Numbers:	K01 AT004415-01, K01AT004415-01, DFCI-08169
Study First Received:	November 21, 2008
Last Updated:	January 18, 2012
Health Authority:	United States: Federal Government

Keywords provided by Dana-Farber Cancer Institute:

acupuncture
dysphagia
chemoradiation related effects
squamous cell carcinoma of the head and neck

nasopharyngeal cancer
oropharynx cancer
hypopharynx cancer
larynx cancer

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Deglutition Disorders
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Squamous Cell
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on February 09, 2012