Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia (NCT01266044) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
United States, China435 participantsStarted 2011-12-09
Plain-language summary
The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years of age and be able to give informed consent.
✓. Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.
✓. Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy).
✓. Anatomically intact parotid and submandibular glands.
✓. Karnofsky performance status \> 60.
Exclusion criteria
✕. History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia.
✕. Prior head and neck radiation treatment.
✕. Suspected or confirmed physical closure of salivary gland ducts on either side.
✕. Known bleeding disorders or taking any dose of warfarin or heparin.
✕. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
✕. Local skin infections at or near the acupuncture sites or active systemic infection.
✕. History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
What they're measuring
1
Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)
✕. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.