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Clinical Trials in China / NCT01266044
Active, not recruiting Phase 3

Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

NCT01266044 · tracked via the Priya Life Science China tracker
Sponsor
M.D. Anderson Cancer Center
Phase
Phase 3
Started
2011-12-09
Last updated
2026-04-16

Condition(s) studied

Head And Neck Cancer

Investigational drug(s) / intervention(s)

Acupuncture - Group 1Acupuncture - Group 2Standard CareQuestionnaire

Acupuncture - Group 1: Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment.

Acupuncture - Group 2: Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment.

Standard Care: Standard oral care recommendations. Participants in all groups will receive the same recommendations.

Questionnaire: Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.

Study 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 and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 18 years of age and be able to give informed consent. 2. 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. 3. 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). 4. Anatomically intact parotid and submandibular glands. 5. Karnofsky performance status \> 60. Exclusion Criteria: 1. 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. 2. Prior head and neck radiation treatment. 3. Suspected or confirmed physical closure of salivary gland ducts on either side. 4. Known bleeding disorders or taking any dose of warfarin or heparin. 5. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory. 6. Local skin infections at or near the acupuncture sites or active systemic infection. 7. History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity. 8. 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. 9. Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria. 10. 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). 11. Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of Texas MD Anderson Cancer Center Houston Texas
Fudan University Cancer Hospital Shanghai China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01266044 on ClinicalTrials.gov ↗ ← All trials in China