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

Completed · Not applicable · Has a placebo group

Conditions studied: Radiation-Induced Xerostomia, Head and Neck Cancer, Radiation Toxicity, Oral Complications of Chemotherapy and Head/Neck Radiation

In brief

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.

Key facts

Study ID

NCT02589938

Run by

Wake Forest University Health Sciences

People needed

258

Starts

2012-11-11

Expected to finish

2022-07-29

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be at least 18 years of age and able to give informed consent.
• Must be able to read, write and understand English.
• Must have a diagnosis of head/neck cancer.
• Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:
• Grade 0 - None
• Grade 1 - Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)
• Grade 2 - Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)
• Grade 3 - Complete dryness of mouth (no response on stimulation and difficult oral alimentation; IV fluids, pureed diet or tube feedings may be required)
• Grade 4 - Fibrosis
• Must have received external beam radiation at a mean dose of at least 24 Gy to one of the parotid glands. The other gland can receive less than 24 Gy.
• Must have completed radiotherapy at least 12 months prior to entry.
• Must have anatomically intact parotid and submandibular glands. A focused (head/neck) history and exam conducted by a physician or dentist within the past year is required.
• Must be acupuncture naïve.
• Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

You may not qualify if…

• History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.
• Suspected or known closure of salivary gland ducts on either side. (Patients addressed in inclusion criteria (i.e. those who have had one submandibular gland removed) are expected to have closure to the removed submandibular gland and will be exempt from this exclusion criteria.)
• Currently receiving or planning to use drugs, herbs, alternative medicines, or devices that could affect salivary production. Treatment known to affect salivation should be stopped at least 14 days prior to enrollment. Over the counter products used for salivary substitution are allowed, but will need to be discontinued for at least 24 hours prior to saliva and questionnaire data collection.
• Have received any investigational new drug within the past 30 days or planning to receive such during the study period.
• Active systemic infection or skin infection at or near the acupuncture sites.
• Receiving chemotherapy during study period.

Where it is running

• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Kaiser Permanente-San Francisco — San Francisco, California, United States
• Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States
• Kaiser Permanente-San Rafael — San Rafael, California, United States
• Kaiser San Rafael-Gallinas — San Rafael, California, United States
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
• Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States
• Kaiser Permanente-South San Francisco — South San Francisco, California, United States
• Kaiser Permanente-Walnut Creek — Walnut Creek, California, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• The Cancer Center of Hawaii-Liliha — Honolulu, Hawaii, United States
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States
• Physicians' Clinic of Iowa PC — Cedar Rapids, Iowa, United States
• Saint Luke's Hospital — Cedar Rapids, Iowa, United States
• Mercy Health Saint Mary's — Grand Rapids, Michigan, United States
• Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States
• Mercy Hospital — Coon Rapids, Minnesota, United States
• Fairview Southdale Hospital — Edina, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Christus Saint Vincent Regional Cancer Center — Santa Fe, New Mexico, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Adena Regional Medical Center — Chillicothe, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.