PCRC_WF97115

PCRC WF97115-A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients with Head and Neck Cancer

This study is being done to find out what effects, good and/or bad, acupuncture has on participants and their xerostomia caused by radiation therapy for the treatment of the cancer.

Key Inclusion Criteria:

• Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified 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.
Phase III
NCT02589938
Cancer, All Other
Oral, Head and Neck
Alison Conlin, M.D.
Wake Forest NCORP Research Base
Amy Greathouse

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.