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Study Summary
No. 2008-0801:.......Head And Neck......Joseph S. Chiang......Behavioral Science
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Study Summary Title
Study Summary
Number:
2008-0801
Study Title:Randomized Pilot Trial of 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:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-4515
Contact us about clinical trials
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General Information
Disease Group:Head And NeckSupported By:N/A
Phase of Study:N/AReturn
Visit:
Patients will not come to MDACC. Patients will receive 3 acupuncture treatments
a week for 7 weeks and then have a follow-up visit at week 11.
Treatment
Agents:
AcupunctureHome Care:NA
Treatment Loc:Only outside MDACC at one or more Collaborating Sites or Institutions
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.
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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 Fudan University Cancer Hospital, 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.

The aims of this study are to:

PRIMARY AIM
1. Determine the feasibility of providing true and sham acupuncture treatment to patients at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation treatment for cancer of the head and/or neck area.

SECONDARY AIMS
2. Determine if true acupuncture is more effective than sham acupuncture for preventing radiation-induced xerostomia among cancer patients at Cancer Hospital.

3. Determine if true acupuncture is more effective than sham acupuncture for reducing the severity of radiation-induced xerostomia.
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Study Status Information
Study Activation / Registration Date:03/13/2009
IRB Review and Approval Date:03/13/2009
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:20
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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 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

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Links
Registration Number: NCT00862550
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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