A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients with Head and Neck Cancer
Disease Group: Malignant neoplasms of lip oral cavity and pharynx
Treatment Agent: Acupuncture
Treatment Location: Both at MDACC & and Other Sites
Sponsor: NCI,5R01CA148707 (NCI)
Primary Objective 1. To determine whether or not acupuncture can symptomatically improve moderate or severe xerostomia (grade 2 or 3) due to head/neck radiotherapy. Secondary Objectives 1. To explore the duration of response (up to a maximum of 6 months) in the subgroup of patients who report a response to the acupuncture intervention. 2. Examine group differences in saliva flow using unstimulated and stimulated whole salivary flow rates. 3. Examine whether true acupuncture results in better overall Quality of Life (QOL) than sham acupuncture or standard of care. 4. Determine the effects of acupuncture on saliva-based factors including pH, buffering capacity, and viscosity as well as levels of total protein, calcitonin-gene related peptide, and vasoactive intestinal polypeptide. 5. Examine the role of expectancy for the benefits of acupuncture in predicting outcomes. The role of expectancy as a moderator of the effects of treatment will be thoroughly examined.
IRB Review and Approval Date: 06/09/2016
Recruitment Status: Open
Projected Accrual: 240
1) Must be at least 18 years of age and able to give informed consent.
2) Must be able to read, write and understand English.
3) Must have a diagnosis of head/neck cancer.
4) 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.
5) 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.
6) Must have completed radiotherapy at least 12 months prior to entry.
7) 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.
8) Must be acupuncture naïve.
9) Must have ECOG performance status of 0-2.
1) History of xerostomia, Sjogren’s disease or other illness known to
affect salivation prior to head/neck radiation.
2) Suspected or known closure of salivary gland ducts on either side.
3) 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.
4) Have received any investigational new drug within the past 30 days or planning to receive such during the study period.
5) Active systemic infection or skin infection at or near the acupuncture sites.
6) Receiving chemotherapy during study period.
Information and next steps
Malignant neoplasms of lip oral cavity and pharynx
Palliative Care and Rehabilitation Medicine
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