Acupuncture in Treating Dry Mouth Caused by Radiation Therapy in Patients with Head and Neck Cancer
- 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; intravenous (IV) fluids, pureed diet or tube feedings may be required) * Grade 4 – Fibrosis
- Must have received external beam radiation with curative intent
- Must have completed radiotherapy at least 12 months prior to entry
- Must have anatomically intact parotid glands and at least one submandibular gland; a focused (head/neck) history and exam conducted by a physician or dentist within the past year is required
- Have never had acupuncture for xerostomia
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- History of xerostomia, Sjogren’s disease or other illness known to affect salivation prior to head/neck radiation
- Suspected or known closure of salivary gland ducts on either side. (Patients addressed in inclusion criteria (i.e. those who have had one submandibular gland removed) are expected to have closure of the duct to the removed submandibular gland and will be exempt from this exclusion criteria.)
- Currently receiving or planning to receive other xerostomia treatment, including drugs, herbs or devices; all other treatments known to affect salivation should be stopped at least 14 days prior to enrollment
- 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
South San Francisco
I. To determine whether or not acupuncture can symptomatically improve moderate or severe xerostomia (grade 2 or 3) due to head/neck radiotherapy.
I. 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.
II. Examine group differences in saliva flow using unstimulated and stimulated whole salivary flow rates.
III. Examine whether true acupuncture results in better overall quality of life (QOL) than sham acupuncture or standard of care.
IV. 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.
V. 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.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.
ARM II: Patients receive acupuncture at 3 sites on each ear, on the chin, on each forearm, on each hand, on each leg, and a placebo needle above the right knee for 20 minutes twice a week for 4 weeks. Patients with minor response may continue treatment for an additional 4 weeks. Patients also receive standard oral hygiene as in Arm I.
ARM III: Patients receive sham acupuncture twice a week for 4 weeks and standard oral hygiene as in Arm I. Patients with minor response may continue treatment for an additional 4 weeks.
After completion of study treatment, patients are followed up at 6 or 7.5 months.
Trial Phase Phase III
Trial Type Supportive care
Wake Forest NCORP Research Base
Suzanne C. Danhauer
- Primary ID MDA-04-01
- Secondary IDs NCI-2011-02073, WF-97115, WF-97115, CDR0000674208, WFU 97115
- Clinicaltrials.gov ID NCT01141231