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

OBJECTIVES:

Primary

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

Secondary

- 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.

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 (XQ) 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 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 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, 8, and12. 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 and at 6 months. Patients in group 2 and 3 also complete the Acupuncture
Expectancy Scale (AES). Saliva is also collected at these time points.

- Coordinating Center: The University of Texas MD Anderson Cancer Center Community
Clinical Oncology Program (CCOP) Research Base

Inclusion Criteria:

1. Must be at least 18 years of age and able to give informed consent.

2. Must have a diagnosis of head/neck cancer.

3. Must have received bilateral radiation therapy, and subsequently developed grade 2 or
3 xerostomia, according to RTOG scale: Grade 0 - None Grade 1 - Slight dryness of
mouth, good response on stimulation Grade 2 - Moderate dryness of mouth, poor response
on stimulation Grade 3 - Complete dryness of mouth, no response on stimulation Grade 4
- Fibrosis

4. Must have received external beam radiation at a mean dose of at least 25 Gy to one of
the parotid glands. The other gland can receive less than 25 Gy. (Chemotherapy during
or subsequent to radiation therapy is allowed).

5. Must have completed radiotherapy at least 12 months prior to entry. Note: Patients
currently receiving radiation therapy not involving radiation to the head and neck may
be eligible to participate in this trial.

6. Must have anatomically intact parotid and submandibular glands.

7. Must be acupuncture naïve.

8. Must not have any history of xerostomia prior to radiation therapy.

9. No active infection.

10. Must have Karnofsky performance status >/= 60 or ECOG performance status of 0-2.

Exclusion Criteria:

1. History of xerostomia, Sjogren's disease or other illness known to affect salivation
prior to head/neck radiation.

2. Suspected or confirmed closure of salivary gland ducts on either side.

3. Currently receiving or planning to use receive other xerostomia treatment, including
drugs, herbs, alternative medicines, or devices that could affect salivary production.
All other tTreatments 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. Previous acupuncture treatment.

6. Active systemic infection or skin infection at or near the acupuncture sites.

7. History of xerostomia prior to the head/neck radiation therapy.