Acupuncture for Prevention of Radiation-Induced Xerostomia
18 Years
N/A
Both
Xerostomia, Mouth Dryness, Nasopharyngeal Cancer
Trial Information
Acupuncture for Prevention of Radiation-Induced Xerostomia
Some research suggests that acupuncture may be helpful in stimulating saliva flow in
patients with dry mouth caused by radiation treatment. Acupuncture uses very thin needles
inserted at certain points on the body that are believed to affect bodily functions.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. Your complete
medical history will be recorded, and you will have a physical exam. You will also be asked
to complete 3 short questionnaires about your quality-of-life and current saliva flow.
These should take about 5 minutes to complete. You will be asked to 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 be asked to collect saliva twice at each time point.
One collection will be like it is described above. The second collection will be after you
have held a sour liquid in your mouth for 1 minute. A traditional Chinese medicine
diagnosis will also be conducted. This will include diagnosis by a doctor as well as by
using a heart-rate machine and taking a photograph of your tongue. This will allow a more
objective check of your heart rate and tongue condition.
If you are found to be eligible to take part in the study, you will be randomly assigned (as
in the toss of a coin) into 1 of 2 groups. One group will receive acupuncture during their
radiation treatment period, and the other will receive standard care without acupuncture.
Participants assigned to the acupuncture group will receive acupuncture for 20 minutes
before their radiation therapy session, 3 days a week for 7 weeks. Participants in the
standard care group will not receive acupuncture.
If you are in the acupuncture group, you will be asked to come to the acupuncture clinic for
the treatment, before your radiation treatment. The acupuncturist will put in the needles
in certain points of your body (including the chin, wrist, leg, and ear), while you are
seated in a chair. The needles will remain in for about 20 minutes.
If you choose to receive medications for dry mouth at any point while on study, your
participation on this study will end.
No matter which group you are assigned to, for each of the 7 weeks you are receiving
radiation treatment, your vital signs (your blood pressure and pulse) will be checked, and
you will be asked about any medications you are taking. You will also complete
questionnaires about your quality-of-life and symptoms. Each questionnaire should take
about 5 minutes to complete. A saliva sample will also be collected on Weeks 1, 3, 4, 6,
and 7. If you are assigned to the acupuncture group, the saliva sample will be collected
after the acupuncture treatment on Weeks 1, 4, and 7 and before the treatment on Weeks 3 and
6. A traditional Chinese medicine diagnosis will also be conducted in the middle of
radiation treatment, at the end of treatment, and 1 month later. This will include diagnosis
by a physician as well as by using a pulse machine and taking a photograph of your tongue.
One month after the end of radiation treatment (Week 11), your vital signs will be checked,
you will be asked about any medications you are taking， you will complete the quality of
life and symptom questionnaires, and you will provide another saliva sample. After Week 11,
your participation on this study is over.
This is an investigational study. Up to 100 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 consent
2. Diagnosed with nasopharyngeal carcinoma and scheduled to undergo concurrent
chemotherapy and radiation treatment
3. Treatment plan must include treatment of at least 50 gray 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.
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. Planned IMRT
3. Suspected or confirmed physical closure of salivary gland ducts on either side
4. Known bleeding disorders and 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 cholinergic agonist medication (Pilocarpine, Cevimeline), beta
adrenergic antagonists, anticholinergic agents or other medications known to affect
salivary function
13. Currently receiving acupuncture for any condition
14. No prior head and neck radiation treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Number of Patients with Xerostomia
Outcome Time Frame:
Baseline + 8 additional points in time (baseline, weeks1-7, week 11).
Safety Issue:
No
Principal Investigator
Joseph S. Chiang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2006-0763
NCT ID:
NCT00430378
Start Date:
January 2007
Completion Date:
Related Keywords:
- Xerostomia
- Mouth Dryness
- Nasopharyngeal Cancer
- Xerostomia
- Dry Mouth
- Mouth Dryness
- Nasopharyngeal Cancer
- Acupuncture
- Xerostomia
- Nasopharyngeal Neoplasms
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