Status:
ACTIVE_NOT_RECRUITING
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head And Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head a...
Detailed Description
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Study Groups: If you are found to be eligible to ...
Eligibility Criteria
Inclusion
- 18 years of age and be able to give informed consent.
- Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.
- Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy).
- Anatomically intact parotid and submandibular glands.
- Karnofsky performance status \> 60.
Exclusion
- History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia.
- Prior head and neck radiation treatment.
- Suspected or confirmed physical closure of salivary gland ducts on either side.
- Known bleeding disorders or taking any dose of warfarin or heparin.
- Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
- Local skin infections at or near the acupuncture sites or active systemic infection.
- History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
- 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.
- Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria.
- Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine, cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function (see Appendix F).
- Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.
Key Trial Info
Start Date :
December 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT01266044
Start Date
December 9 2011
End Date
December 31 2026
Last Update
October 27 2025
Active Locations (2)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Fudan University Cancer Hospital
Shanghai, China