Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia (NCT02292368) | Clinical Trial Compass
CompletedNot Applicable
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia
United States, China30 participantsStarted 2014-11-10
Plain-language summary
The goal of this clinical research study is to learn which areas of the brain respond to acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve patient quality of life.
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 nasopharyngeal, and scheduled to undergo IMRT or proton with or without concurrent chemotherapy at MD Anderson or Fudan University.
✓. 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.
✓. Must be right-handed.
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 (ie, missing limbs or scars that prevent needle insertion at the acupuncture points) that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
✕
What they're measuring
1
Relative Changes of EEG Scores Between Pre- and Post-Acupuncture
. Local skin infections at or near the acupuncture sites or are under treatment for active systemic infection.
✕. History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
✕. Documented history of mental incapacitation or significant emotional or psychiatric disorder (i.e. bipolar, schizophrenia) 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.