Expired Study
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Boston, Massachusetts 02115


Purpose:

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 difficulty with swallowing, is a common and expected side effect during and following CRT. Dysphagia occurs in up to 50% of patients and significantly impairs the quality of life (QOL) of patients during delivery of and recovery from CRT. Clinical trials evaluating promising and innovative adjunctive approaches that could increase the rate and magnitude of recovery from dysphagia in HNC patients are needed. Acupuncture is a traditional Chinese medical technique that has been found to reduce symptoms and side effects associated with primary cancer therapy. This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture.


Study summary:

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 efficacy of acupuncture in changing scores of HRQOL in post CRT head and neck cancer patients. Aim 3. (Exploratory) In a subset of HNC subjects treated with both active and sham acupuncture, to collect objective measures on swallowing functions using Videofluoroscopic swallowing study (VFSS); salivary flow production; and plasma Transforming Growth Factor (TGF)-β1, Interleukin 6 (IL-6), Tumor necrosis factor-alpha (TNF-α) and Interleukin 13 levels.


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;


NCT ID:

NCT00797732


Primary Contact:

Principal Investigator
Weidong Lu, MB, MPH, PhD
Harvard Medical School/Dana-Farber Cancer Institute


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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