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Acupuncture for Radiation-Induced Dry Mouth

Phase 3
Waitlist Available
Led By Lorenzo Cohen, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will study if acupuncture can help prevent dry mouth and improve quality of life for patients who have received radiation to the head and neck.

Who is the study for?
This trial is for adults with head and neck cancer, primarily oropharyngeal, who are about to receive IMRT possibly with chemotherapy. Participants must have intact salivary glands and a performance status indicating they can carry out daily activities. Excluded are those with prior dry mouth issues, previous radiation treatment in the area, certain systemic illnesses like Sjögren's disease, bleeding disorders, deformities affecting acupuncture points, skin infections near acupuncture sites, CNS injuries or severe mental/emotional conditions.Check my eligibility
What is being tested?
The study tests if acupuncture can prevent dry mouth caused by radiation therapy in head and neck cancer patients. It compares two different acupuncture techniques against standard care without acupuncture to see which is more effective at preventing xerostomia and improving quality of life.See study design
What are the potential side effects?
Acupuncture may cause minor side effects such as slight pain where needles are inserted, bruising or bleeding at the sites, dizziness or fainting. Serious side effects are rare but could include infection or injury from needles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Standard CareExperimental Treatment2 Interventions
Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - 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.
Group II: Acupuncture - Group 1Experimental Treatment3 Interventions
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - 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.
Group III: Acupuncture - Group 2Active Control3 Interventions
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - 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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,367 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,232 Total Patients Enrolled
Lorenzo Cohen, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
10 Previous Clinical Trials
1,395 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we enrolling people in this research project at the moment?

"No, this study is not recruiting patients at the moment according to clinicaltrials.gov. This research project was first made public on December 9th 2011 and updated as recently as April 27th 2022. Even though this trial isn't looking for volunteers, there are 56 other studies that are actively searching for participants right now."

Answered by AI

Does Acupuncture - Group 1 have any harmful side effects?

"There is a significant body of evidence supporting the safety of acupuncture, so it received a score of 3."

Answered by AI
Recent research and studies
JAMA Network OpenJournal
Effect of True and Sham Acupuncture on Radiation-induced Xerostomia Among Patients with Head and Neck Cancer
Garcia, M. Kay, Zhiqiang Meng, David I. Rosenthal, Yehua Shen, Mark Chambers, Peiying Yang, Qi Wei, et al.. 2019. “Effect of True and Sham Acupuncture on Radiation-induced Xerostomia Among Patients with Head and Neck Cancer”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2019.16910.
clinicaltrials.govStudy
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
2011. "Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01266044.
~77 spots leftby Dec 2026
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