Status:
COMPLETED
A Pilot Study of Acupuncture Treatment for Dysphagia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Carcinomas, Squamous Cell
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The current standard of care for advanced HNC is concurrent chemoradiation therapy (CRT), which has led to increased survival rates, but with significant acute and long-term toxicities. Dysphagia, or ...
Detailed Description
AIMS: Aim 1. To assess the feasibility of recruiting and retaining HNC patients with dysphagia into a randomized sham-controlled trial of acupuncture. Aim 2. To collect preliminary data on the effic...
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00797732
Start Date
December 1 2008
End Date
August 1 2015
Last Update
February 13 2018
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115