Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer

Inclusion Criteria

• •Must be at least 18 years of age and able to give informed consent.
• •Must be able to read, write and understand English.
• •Must have a diagnosis of head/neck cancer.
• •Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:
• •* Grade 0 - None
• •* Grade 1 - Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)
• •* Grade 2 - Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)
• •* Grade 3 - Complete dryness of mouth (no response on stimulation and difficult oral alimentation; IV fluids, pureed diet or tube feedings may be required)
• •* Grade 4 - Fibrosis
• •Must have received external beam radiation at a mean dose of at least 24 Gy to one of the parotid glands. The other gland can receive less than 24 Gy.
• •Must have completed radiotherapy at least 12 months prior to entry.
• •Must have anatomically intact parotid and submandibular glands. A focused (head/neck) history and exam conducted by a physician or dentist within the past year is required.
• •Must be acupuncture naïve.
• •Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• •Currently receiving or planning to use drugs, herbs, alternative medicines, or devices that could affect salivary production. Treatment known to affect salivation should be stopped at least 14 days prior to enrollment. Over the counter products used for salivary substitution are allowed, but will need to be discontinued for at least 24 hours prior to saliva and questionnaire data collection.
• •Have received any investigational new drug within the past 30 days or planning to receive such during the study period.
• •Active systemic infection or skin infection at or near the acupuncture sites.
• •Receiving chemotherapy during study period.