Status:
COMPLETED
Acupuncture for Prevention of Radiation-Induced Xerostomia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Xerostomia
Mouth Dryness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Rese...
Detailed Description
Some research suggests that acupuncture may be helpful in stimulating saliva flow in patients with dry mouth caused by radiation treatment. Acupuncture uses very thin needles inserted at certain point...
Eligibility Criteria
Inclusion
- Adult \>/= 18 year of age and able to sign informed consent
- Diagnosed with nasopharyngeal carcinoma and scheduled to undergo concurrent chemotherapy and radiation treatment
- Treatment plan must include treatment of at least 50 gray bilateral to the parotid
- Must have anatomically intact parotid and submandibular glands
- Karnofsky Performance Status \> 60
- If the participant is female and of child bearing potential, must have a negative urine pregnancy test.
Exclusion
- History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease or other underlying systemic illness known to cause xerostomia).
- Planned IMRT
- Suspected or confirmed physical closure of salivary gland ducts on either side
- Known bleeding disorders and on Heparin or Coumadin
- 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 site or active systemic infection
- 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.)
- 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
- 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
- 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
- Participants taking cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents or other medications known to affect salivary function
- Currently receiving acupuncture for any condition
- No prior head and neck radiation treatment
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 27 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00430378
Start Date
January 1 2007
End Date
May 27 2021
Last Update
June 10 2021
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, China