Status:
UNKNOWN
Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Acupuncture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Purpose: Rationale: Acupuncture is a therapy for physical activity disorders secondary to nervous diseases, and it may have therapeutic effects on dysphagia caused by radiation therapy. Purpose: Thi...
Detailed Description
OBJECTIVE Primary: To determine the therapeutic efficacy of acupuncture on radiotherapy-induced dysphagia in patients with head and neck cancer. Secondary: 1. To determine whether acupuncture can ...
Eligibility Criteria
Inclusion
- Patients must have received radiation therapy for histologically confirmed head and neck cancer;
- Prior irradiation \>/= 6 months prior to study entry;
- Age\>/= 18 years;
- Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< 2 \* ULN, creatinine \<1.5 \* ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; PT, APTT, INR in a normal range;
- Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.
Exclusion
- Evidence of metastatic disease or tumor recurrence, tumor invasion to major vessels (e.g. the carotid);
- Evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- History of seizures or bleeding related to tumor or radiotherapy during or after the completion of radiation;
- History of coagulation defects or allergy history of contrast agent;
- History of disorder that affects swallowing, including brain stroke, oral or throat disease, malignances diseases, infection of the nervous system, demyelinating disease, neurodegenerative disease, advanced dementia, diabetes, peripheral vascular disease, HIV infection, familial degenerative peripheral neuropathy;
- Severe complications: 1) New York heart association grade II or greater congestive heart failure; 2) Serious and inadequately controlled cardiac arrhythmia; 3) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 4) Clinically significant peripheral vascular disease; 5) significant uncontrolled life-threatening infection;
- Prior use of acupuncture for dysphagia;
- Enrolled in other clinical trials.
Key Trial Info
Start Date :
June 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2020
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT03336775
Start Date
June 21 2018
End Date
July 30 2020
Last Update
January 21 2020
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120