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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00797732 |
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 |
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Carcinomas, Squamous Cell Dysphagia |
Device: Acupuncture |
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 |
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 |
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Active Acupuncture: Active Comparator |
Device: Acupuncture
active acupuncture (n=18) or sham acupuncture (n=18), once a week for 12 weeks.
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Sham Acupuncture: Sham Comparator |
Device: Acupuncture
active acupuncture (n=18) or sham acupuncture (n=18), once a week for 12 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with the following criteria will NOT be eligible for the study:
Contact: Zach Jaffa, BS | 617-632-5260 | Zachary_Jaffa@DFCI.HARVARD.EDU |
United States, Massachusetts | |
Zakim Center for Integrative Therapies | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Weidong Lu, MB, MPH, Lic Ac | Harvard Medical School/Dana-Farber Cancer Institute |
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 |
acupuncture dysphagia chemoradiation related effects squamous cell carcinoma of the head and neck |
nasopharyngeal cancer oropharynx cancer hypopharynx cancer larynx cancer |
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 |
Neoplasms Neoplasms by Histologic Type |