Acupuncture needles take on radiation dry mouth in major trial
NCT ID NCT01266044
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether acupuncture can prevent dry mouth (xerostomia) in 435 head and neck cancer patients receiving radiation. Participants are split into two different acupuncture groups or a standard care group. The study compares which approach better reduces dry mouth symptoms and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acupuncture
- What this could lead to
- If it works, this could offer a drug-free way to prevent dry mouth in head and neck cancer patients undergoing radiation, improving their quality of life.
- What could go wrong
- This is a Phase 3 trial, but results are not yet reported. Acupuncture may not be more effective than standard care, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 435 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2011
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fudan University Cancer Hospital
Shanghai, China
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer