Status:
COMPLETED
Neurological Effects 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:
NA
Brief Summary
The goal of this clinical research study is to learn which areas of the brain respond to acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck cancer. Researche...
Detailed Description
Dry mouth is a common problem in cancer patients who have received radiation treatment to the head and neck. Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, ...
Eligibility Criteria
Inclusion
- 18 years of age and be able to give informed consent.
- Diagnosed with head and neck cancer, which will be primarily nasopharyngeal, and scheduled to undergo IMRT or proton with or without concurrent chemotherapy at MD Anderson or Fudan University.
- 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.
- Must be right-handed.
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 (ie, missing limbs or scars that prevent needle insertion at the acupuncture points) 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 are under treatment for active systemic infection.
- History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
- Documented history of mental incapacitation or significant emotional or psychiatric disorder (i.e. bipolar, schizophrenia) 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.
- Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.
Key Trial Info
Start Date :
November 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02292368
Start Date
November 10 2014
End Date
August 30 2022
Last Update
September 1 2022
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, 200433