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A Pilot Study of Acupuncture Treatment for Dysphagia
This study is not yet open for participant recruitment.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), November 2008
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
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

MedlinePlus related topics: Acupuncture Cancer Head and Neck Cancer Swallowing Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title: Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • QOL questionnaires will be measured at baseline, 6 weeks, 12 weeks, and 9 months. [ Time Frame: baseline, 6 weeks, 12 weeks and 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: December 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Acupuncture: Active Comparator Device: Acupuncture
active acupuncture (n=18) or sham acupuncture (n=18), once a week for 12 weeks.
Sham Acupuncture: Sham Comparator Device: Acupuncture
active acupuncture (n=18) or sham acupuncture (n=18), once a week for 12 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
  • Primary tumor sites eligible: nasopharyngeal, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknkown primary squamous cell carcinoma in the neck will also be eligible;
  • Completed radiation therapy, beginning 8-12 weeks, up to 20 weeks;
  • No measurable, persistent, or recurrent tumor that is ascertained by a formal restaging process by the study team
  • 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 > 1.0x10^9/L, platelet count > 50x10^9/L;
  • Signed informed consent.

Exclusion Criteria:

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

  • SCCHN patients with tumor site at oral cavity
  • SCCHN patients enrolled in other investigational trials
  • 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

Contacts
Contact: Zach Jaffa, BS 617-632-5260 Zachary_Jaffa@DFCI.HARVARD.EDU

Locations
United States, Massachusetts
Zakim Center for Integrative Therapies
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Weidong Lu, MB, MPH, Lic Ac Harvard Medical School/Dana-Farber Cancer Institute
  More Information

Responsible Party: Harvard Medical School/Osher Research Center, Dana-Farber Cancer Institute ( Weidong Lu )
Study ID Numbers: K01 AT004415-01, DFCI-08169
Study First Received: November 21, 2008
Last Updated: November 21, 2008
ClinicalTrials.gov Identifier: NCT00797732  
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
acupuncture
dysphagia
chemoradiation related effects
squamous cell carcinoma of the head and neck
nasopharyngeal cancer
oropharynx cancer
hypopharynx cancer
larynx cancer

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Esophageal disorder
Gastrointestinal Diseases
Squamous cell carcinoma
Pharyngeal Diseases
Carcinoma
Epidermoid carcinoma
Deglutition Disorders
Nasopharyngeal carcinoma
Digestive System Diseases
Head and Neck Neoplasms
Carcinoma, squamous cell
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Esophageal Diseases
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009