Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia
18 Years
N/A
Both
Head and Neck Cancer, Xerostomia
Trial Information
Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia
Acupuncture is the use of very thin needles that are stuck in your skin at certain areas of
the body, acupuncture is believed to affect bodily function.
Screening Tests:
Signing this consent form does not mean that you will be able to take part in this study.
You will have "screening tests" to help the doctor decide if you are eligible to take part
in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
- You will complete 3 short questionnaires about your quality-of-life and current saliva
flow. It will take about 5 minutes to complete all the questionnaires.
- Two (2) saliva samples will be collected. To collect the first saliva sample, you will
collect saliva in a vial (small tube or jar) for 5 minutes, by allowing saliva to
collect in your mouth and then spitting it into the vial. You will wait 5 minutes and
then hold a sour liquid in your mouth for 1 minute. Then a second saliva sample will be
collected.
- A traditional Chinese medicine diagnosis will be performed. During this diagnosis,
your pulse will be checked and photographs of your tongue will be taken. You will not
be able to be identified by the photos. The photos will be destroyed when the study is
complete. This will allow a more objective check of your tongue condition.
- Women who are able to become pregnant must have a negative urine pregnancy test.
The study doctor will discuss the screening test results with you. If the screening tests
show that you are not eligible to take part in the study, you will not be enrolled. Other
options will be discussed with you.
Study Groups:
If you are found to be eligible to take part in the study, you will be randomly assigned (as
in the flip of a coin) into 1 of 2 groups. Both groups will have acupuncture sessions for 20
minutes before radiation therapy treatments.
- If you are in Group 1, you will have the needles stuck in areas that are known to help
dry mouth.
- If you are in Group 2, you will have the needles stuck in areas that are not known to
help dry mouth.
When the study is over, participants in Group 2 will be offered 1 week of acupuncture (3
treatments) in the areas known to help dry mouth.
Acupuncture:
All acupuncture sessions will be done before your radiation therapy 3 days a week for 7
weeks. The acupuncturist will put in the needles in certain areas of your body (including
your chin, wrist, leg, and ear) while you are lying on a bed. The needles will remain in
your body for about 20 minutes.
Study Visits:
Both groups will have the following tests and procedures performed before each acupuncture
treatment, once a week:
- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be
measured.
- You will be asked about any drugs you may be taking.
- You will complete the same questionnaires that you filled out during the screening
tests.
Saliva samples will be collected on Weeks 1, 3, 4, 6, and 7. The samples will be collected
the same way as done in screening. The samples will be collected after the acupuncture
sessions on Weeks 1, 4, and before the acupuncture on Weeks 3 and 6.
You will have the Chinese medicine diagnosis on Weeks 3 and 7.
Length of Study:
You will be on study for 11 weeks. You will be taken off study if the condition gets worse
or if intolerable side effects occur. You will be taken off study if you take any drugs for
dry mouth.
End-of-Study Visit:
You will have an end-of-study visit 1 month after your last radiation treatment (Week 11).
The following tests and procedures will be performed:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking.
- You will complete the quality-of-life and saliva flow questionnaires.
- You will have the 2 saliva samples a saliva sample will be collected.
- You will have the Chinese medicine diagnosis.
This is an investigational study. Up to 23 patients will take part in this study. All will
be enrolled at the Fudan University Cancer Hospital.
Inclusion Criteria:
1) Adult >/= 18 year of age and able to sign informed consent2) Diagnosed with nasopharyngeal carcinoma and scheduled to undergo IMRT
3) Treatment plan must include treatment at a mean dose of 25 gray or more bilateral to
the parotid
4) Must have anatomically intact parotid and submandibular glands
5) Karnofsky Performance Status > 60
6) If the participant is female and of child bearing potential, must have a negative urine
pregnancy test. (Acupuncture should be used cautiously during pregnancy since some points
have been shown to stimulate uterine contractions
Exclusion Criteria:
1. History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease
or other 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 on Heparin or Coumadin
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 site or active systemic infection
7. History of cerebrovascular accident or spinal cord injury. (The mechanism of action
for acupuncture may be associated with central nervous system (CNS) activity, and
patients with CNS pathology may respond differently to treatment than the general
population.)
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. Participants who are taking or who have taken any investigational new drug within the
last 30 days, or who are planning to take such a drug during the course of the study
11. Current acknowledged use of other alternative medicines such as herbal preparations
that could affect salivary function. Each patient will be asked for a list of herbal
supplements they are currently taking and this will be reviewed on an individual
basis. Patients will be excluded if they are taking any herbs known or suspected to
affect salivary function
12. Participants taking amifostine, cholinergic agonist medication (Pilocarpine,
Cevimeline), beta adrenergic antagonists, anticholinergic agents, saliva substitutes
or other medications known to affect salivary function
13. Currently receiving acupuncture for any condition
14. Prior use of acupuncture
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Subject Recruitment (#)
Outcome Description:
Feasibility determined by how many eligible patients approached consented to be in the trial and patients' reported satisfaction with the study
Outcome Time Frame:
2 Years
Safety Issue:
No
Principal Investigator
Joseph S. Chiang, MD, MS, BS
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2008-0801
NCT ID:
NCT00862550
Start Date:
March 2009
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Xerostomia
- Head and Neck Cancer
- HNC
- Nasopharyngeal carcinoma
- Acupuncture
- Radiation-Induced Xerostomia
- Xerostomia
- Dry Mouth
- Radiation
- Head and Neck Neoplasms
- Xerostomia
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