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Study Summary
No. 2006-0763:.......Other Supportive......Joseph S. Chiang......Anesthesiology
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Study Summary Title
Study Summary
Number:		2006-0763
Study Title:Acupuncture for Prevention of Radiation-Induced Xerostomia
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Physician New Patient Referral
Name:Joseph S. ChiangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:AnesthesiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5363
Contact us about clinical trials
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General Information
Disease Group:Other SupportiveSupported By:N/A
Phase of Study:N/AReturn
Visit:		Patients will not come to MDACC for anything.
Treatment
Agents:		AcupunctureHome Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		0
Description/
Intervention:		The goal of this clinical research study is to learn if acupuncture is
effective in preventing xerostomia (dry mouth) in cancer patients who receive
radiation treatment to the head and neck area. Researchers also want to learn
whether acupuncture lowers the severity of dry mouth that is experienced by
these patients.
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Study Objectives / Outcomes
This protocol is part of a larger grant funded by the NCI to create an international research center to study Traditional Chinese Medicine. All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.

Study aims:

PRIMARY AIM:
1. Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the head and neck area.

SECONDARY AIMS:
2. Determine whether acupuncture reduces the severity of xerostomia.

3. Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment for cancer of the head and/or neck area.

Prior to receiving radiation treatment, patients will be randomized to one of two groups. Group 1 (G1) will receive acupuncture treatment during the radiation treatment period, and Group 2 (G2) will receive standard care without acupuncture. For aim 1, we hypothesize that there will be a significantly lower incidence of xerostomia among patients who receive acupuncture treatment during radiation than patients who do not receive acupuncture. For aim 2, we hypothesize that the severity of xerostomia will be lower in those who receive acupuncture than in those who do not. For aim 3, we hypothesize that it will be feasible to provide acupuncture to this patient population based on patient recruitment, completion of acupuncture treatments and questionnaires, compliance with collection of saliva samples, and attrition during the treatment and follow-up periods.
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Study Status Information
Study Activation / Registration Date:01/04/2007
IRB Review and Approval Date:11/01/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:100
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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
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Links
Registration Number: NCT00430378
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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