Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer (NCT02589938) | Clinical Trial Compass
CompletedNot Applicable
Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
United States258 participantsStarted 2012-11-11
Plain-language summary
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.
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:
* 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.
Exclusion Criteria:
* History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.
* Suspec…
What they're measuring
1
Xerostomia Questionnaire Scores
Timeframe: Baseline to 4, 8, 12, 26 weeks post acupuncture