A Pilot Study of Acupuncture Treatment for Dysphagia
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/15/2018 |
| Start Date: | December 2008 |
| End Date: | August 2015 |
Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial
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.
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.
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.
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.
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;
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