Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

Running, not enrolling · Phase 3

Conditions studied: Head And Neck Cancer

In brief

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.

Key facts

Study ID

NCT01266044

Run by

M.D. Anderson Cancer Center

People needed

435

Starts

2011-12-09

Expected to finish

2026-12-31

Last updated by the study team

2026-04-16

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 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.

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 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.
• 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.
• Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria.
• Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine, cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function (see Appendix F).
• 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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