Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT00797732
Eligibility 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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00797732
Study Brief:
Protocol Section:
NCT00797732