NCT01266044Active, not recruitingPhase 3
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 435 (estimated)
- First submitted
- 22 Dec 2010
- Start date
- 9 Dec 2011
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT01266044
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 435
- From 9 Dec 2011 to the primary completion date, 31 Dec 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
- Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.
Other illness
- Known bleeding disorders or taking any dose of warfarin or heparin.
- Local skin infections at or near the acupuncture sites or active systemic infection.
- History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
- 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.
Other
- Suspected or confirmed physical closure of salivary gland ducts on either side.
- Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
Who the study is looking for
- 18 years of age and be able to give informed consent.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Cancer hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
Related publications
- The differential effects of social support on quality of life in head and neck cancer patients in the United States and China.Eur J Oncol Nurs · 2026 · PMID 41723882
This page is information, not medical advice. Discuss any trial with your doctor.