Status:
UNKNOWN
Xerostomia Pilot Fudan: Acupuncture for Prevention of Radiation-Induced Xerostomia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Head and Neck Cancer
Xerostomia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 c...
Detailed Description
Acupuncture is the use of very thin needles that are stuck in your skin at certain areas of the body, acupuncture is believed to affect bodily function. Screening Tests: Signing this consent form do...
Eligibility Criteria
Inclusion
- 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
- History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease or other 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 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 amifostine, cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents, saliva substitutes or other medications known to affect salivary function
- Currently receiving acupuncture for any condition
- Prior use of acupuncture
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00862550
Start Date
March 1 2009
End Date
March 1 2022
Last Update
December 30 2020
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, China