Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia

Completed · Not applicable

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT02292368

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2014-11-10

Expected to finish

2022-08-30

Last updated by the study team

2022-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria.
• Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Fudan University Cancer Hospital — Shanghai, China

Full record on ClinicalTrials.gov

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