Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile,
stainless steel needles into the skin at specific points.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the roll of a dice) into 1 of 3 groups.

Group 1 will receive acupuncture during the radiation treatment period.

Group 2 will receive acupuncture at different points on the body than those in Group 1 during
the radiation treatment period.

You will not know if you are assigned to Group 1 or 2.

Group 3 will receive standard care without any kind of acupuncture during the radiation
treatment period.

Study Visits:

If you are in Group 1 and 2, you will receive up to 21 acupuncture treatments with no more
than 3 treatments per week during your regularly scheduled radiotherapy visits. It will take
about 20 minutes to complete the acupuncture session each time.

No matter which group you are assigned to, you will complete the following at the middle and
end of radiotherapy treatment, and again 2-4, 5-9, 10-15 months after radiotherapy treatment
is complete:

- Your vital signs will be recorded.

- You will be asked about any drugs you are taking.

- You will complete 9 questionnaires about your dry mouth, quality of life, and mood. It
should take about 30 minutes in total to complete the questionnaires. If you are not
able to complete the questionnaires during your regularly scheduled visits, you will be
able to take the questionnaires home to complete them and will be given a postage-paid
return envelope to mail them back to the study doctor.

- A saliva sample will be collected to measure the quality and amount of saliva produced
during radiotherapy.

- You will complete a form about your oral hygiene that should take about 5 minutes to
complete.

Length of Study:

You will remain on study for up to 17 months.

Additional Information:

After your participation on this study is complete and you are no longer enrolled in this
study, if you were in Group 2 or 3, you will be offered to receive 3 acupuncture treatments.

This is an investigational study.

Up to 435 patients will take part in this multicenter study. Up to 193 will be enrolled at MD
Anderson.

Inclusion Criteria:

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

2. Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and
scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.

3. Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy
or more to one of the parotid glands (the other gland can receive less than 24 Gy).

4. Anatomically intact parotid and submandibular glands.

5. Karnofsky performance status > 60.

Exclusion Criteria:

1. History of xerostomia prior to head and neck radiation therapy or history of Sjögren's
disease or another underlying systemic illness known to cause xerostomia.

2. Prior head and neck radiation treatment.

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

4. Known bleeding disorders or taking any dose of warfarin or heparin.

5. Upper or lower extremity deformities that could interfere with accurate acupoint
location or alter the energy pathway as defined by traditional acupuncture theory.

6. Local skin infections at or near the acupuncture sites or active systemic infection.

7. History of cerebrovascular accident or spinal cord injury since the mechanism of
acupuncture may be associated with central nervous system activity.

8. Mental incapacitation or significant emotional or psychiatric disorder that, in the
opinion of the investigator, precludes study entry as these patients may not be able
to cooperate with this slightly invasive procedure or with the data collection
process.

9. Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined
by The American Psychiatric Association criteria.

10. Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine,
cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any
saliva substitute or other medication/herbal preparation known to affect salivary
function (see Appendix F).

11. Patients who are currently receiving acupuncture for any condition or if they have
ever had acupuncture before.