Acupuncture in Treating Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer

2014-07-23 21:08:49 | BioPortfolio


RATIONALE: Acupuncture may help relieve dry mouth caused by radiation therapy.

PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared to sham acupuncture or standard therapy in treating dry mouth caused by radiation therapy in patients with head and neck cancer.




- To determine whether acupuncture can symptomatically improve moderate or severe radiation-induced xerostomia (grade 2 or 3) in patients with head and neck cancer.


- To explore the duration of response (up to a maximum of 12 weeks) in the subgroup of patients who report a response to the acupuncture intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease, age, sex, the mean of parotid radiotherapy doses received, and baseline Xerostomia Questionnaire scores. 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, and on each leg 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 1.

- Arm III: Patients receive sham acupuncture twice a week for 4 weeks and standard oral hygiene as in arm 1. Patients with minor response may continue treatment for an additional 4 weeks.

Patients complete Xerostomia Questionnaire (XQ), the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), and the Functional Assessment of Cancer Therapy (FACT-G) questionnaires at baseline and at the end of weeks 4 and 8. Patients with partial response or minor response, according to week-8 questionnaires, complete XQ, MDASI-HN, and the FACT-G at the end of week 12. Patients in group 2 and 3 also complete the Acupuncture Expectancy Scale (AES).

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Single Blind, Primary Purpose: Supportive Care


Head and Neck Cancer


acupuncture therapy, sham intervention, standard follow-up care


Not yet recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:08:49-0400

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Acupuncture therapy by inserting needles in the ear. It is used to control pain and for treating various ailments.

The occupational discipline of the traditional Chinese methods of ACUPUNCTURE THERAPY for treating disease by inserting needles along specific pathways or meridians.

A type of massage in which finger pressure on specific body sites is used to promote healing, relieve fatigue, etc. Although the anatomical locations are the same as the ACUPUNCTURE POINTS used in ACUPUNCTURE THERAPY (hence acu-), no needle or other acupuncture technique is employed in acupressure. (From Random House Unabridged Dictionary, 2d ed). Shiatsu is a modern outgrowth that focuses more on prevention than healing.

Specialized healthcare delivered as a follow-up or referral from a PRIMARY CARE provider.

A traditional term for all the activities which a physician or other health care professional normally performs to insure the coordination of the medical services required by a patient. It also, when used in connection with managed care, covers all the activities of evaluating the patient, planning treatment, referral, and follow-up so that care is continuous and comprehensive and payment for the care is obtained. (From Slee & Slee, Health Care Terms, 2nd ed)

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