NCT02589938

Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer

A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to find out what effects, good and/or bad, acupuncture has on participants and their xerostomia caused by radiation therapy for the treatment of the cancer.

Detailed description

Patients who have met all eligibility criteria will be randomized to standard oral hygiene, standard oral hygiene + true acupuncture twice weekly for 4 weeks, or standard oral hygiene + sham acupuncture twice weekly for 4 weeks by a form of adaptive randomization, called minimization, because simple randomization could result in covariate imbalances . The acupuncture points will be at three sites on each ear (Shenmen, Point Zero, Salivary Gland 2-prime), a site on the chin (CV24), a site on each forearm (Lu7), a site on each hand (LI 1-prime), a site on each leg (K6), and one placebo needle at Gb32 for a total of 14 sites. All sites will be applied for 20 minutes. For body points, standardized techniques for location will be utilized, which are based on anatomical landmarks as well as proportional measurements using the patient's own body. For example, finger breadth is based on each patient's middle finger, and the proportional unit of measure, the "cun," is defined as the distance between the two medial ends of the creases of the interphalangeal joints when the middle finger is flexed. Ear point locations will mimic standard practice and be identified by the acupuncturists.

Conditions

• Radiation-Induced Xerostomia
• Head and Neck Cancer
• Radiation Toxicity
• Oral Complications of Chemotherapy and Head/Neck Radiation

Interventions

Type	Name	Description
OTHER	Standard Oral Hygiene	Oral hygiene care provided per individual institutions standard of care.
OTHER	Standard Oral Hygiene + True Acupuncture	Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
OTHER	Standard Oral Hygiene + Sham Acupuncture	Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.

Timeline

• Start date: 2012-11-11
• Primary completion: 2022-07-29
• Completion: 2022-07-29
• First posted: 2015-10-28
• Last updated: 2026-02-27
• Results posted: 2024-09-19

Locations

36 sites across 1 country: United States