Acupuncture for Prevention of Radiation-Induced Xerostomia (NCT00430378) | Clinical Trial Compass
CompletedNot Applicable
Acupuncture for Prevention of Radiation-Induced Xerostomia
China100 participantsStarted 2007-01
Plain-language 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. Researchers also want to learn whether acupuncture lowers the severity of dry mouth that is experienced by these patients.
Primary Objective:
-Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the head and neck area.
Secondary Objectives:
* Determine whether acupuncture reduces the severity of xerostomia.
* Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment for cancer of the head and/or neck area.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Number of Patients with Xerostomia
Timeframe: Baseline + 8 additional points in time (baseline, weeks1-7, week 11).
. 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