Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
NCT01266044 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 435
Last updated 2026-04-16
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.
Conditions
Interventions
- PROCEDURE
-
Acupuncture - Group 1
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment.
- PROCEDURE
-
Acupuncture - Group 2
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment.
- OTHER
-
Standard Care
Standard oral care recommendations. Participants in all groups will receive the same recommendations.
- OTHER
-
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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Lorenzo Cohen, PHD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-12-09
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United States
- China
Study Locations
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