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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00862550 |
Purpose
PRIMARY AIM
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
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer Xerostomia |
Other: Acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia |
| Estimated Enrollment: | 23 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Acupuncture (Areas known to help dry mouth)
|
Other: Acupuncture
20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.
|
|
Experimental: Group 2
Acupuncture (Areas not known to help dry mouth)
|
Other: Acupuncture
20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations
More Information
| Responsible Party: | Joseph S. Chiang, MD, MS, BS / Professor, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00862550 History of Changes |
| Other Study ID Numbers: | 2008-0801 |
| Study First Received: | March 16, 2009 |
| Last Updated: | May 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Head and Neck Cancer HNC Nasopharyngeal carcinoma Acupuncture |
Radiation-Induced Xerostomia Xerostomia Dry Mouth Radiation |
|
Head and Neck Neoplasms Xerostomia Neoplasms by Site Neoplasms |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |