A Pilot Study of Acupuncture Treatment for Dysphagia
This trial has been completed.
|Conditions||carcinomas, squamous cell, dysphagia|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Center for Complementary and Integrative Health (NCCIH)|
|Start date||December 2008|
|End date||January 2013|
|Trial size||42 participants|
|Trial identifier||NCT00797732, DFCI-08169, K01AT004415-01|
This study is a pilot randomized, sham-controlled trial of acupuncture for Head and Neck Cancer (HNC) patients with dysphagia after chemoradiation therapy (CRT). The following hypotheses will be evaluated:
Aim 1. HNC patients will be willing and eligible to participate in a clinical trial of acupuncture, and be adherent to protocol acupuncture and baseline and follow-up outcomes testing.
Aim 2. At 20 weeks post CRT and 6 months following the acupuncture treatment: a) the MDADI total score and its sub-scores will be higher in active acupuncture vs. sham control; b) the time-to-removal of the feeding tube will be shorter in the active acupuncture vs. sham control; c) body weight recovery will increase faster in active acupuncture vs. sham control.
Aim 3. At 20 weeks post CRT, the plasma Transforming Growth Factor (TGF)-β1 level measured in patients treated with acupuncture will demonstrate trends of a decreased level when compared with a group of similar patients treated with sham acupuncture.
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
|Masking||participant, outcomes assessor|
time frame: Assessed during the entire enrollment period which at study completion was determined to be approximately 3 years.
time frame: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks).
MDADI change from baseline to 12 months post chemoradiation therapy (CRT)
time frame: Assessed at baseline, 2-, 4-, 8-, 12- and 20-wks during acupuncture treatment and long-term at 6 mos post-treatment which parallels 12 mos post-CRT
All participants at least 18 years old.
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;
|Official title||Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial|
|Principal investigator||Weidong Lu, MB, MPH, PhD|
|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 efficacy of acupuncture in changing scores of HRQOL in post CRT head and neck cancer patients. Aim 3. 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.|
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