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

Head and Neck Cancer Clinical Trial

— ACUPUNCTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589938
• Other study ID #: IRB00038707
• Secondary ID: REBAWF 97115NCI-
• Status: Completed
• Phase: N/A
• Start date: November 11, 2012
• Est. completion date: July 29, 2022

Study information

• Verified date: July 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. Earpoint locations will mimic standard practice and be identified by the acupuncturists.

Other known NCT identifiers

• NCT01141231

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 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 ECOG performance status of 0-2.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Standard Oral Hygiene
Oral hygiene care provided per individual institutions standard of care.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina
United States	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California
United States	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa
United States	Saint Luke's Hospital	Cedar Rapids	Iowa
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio
United States	MD Anderson in The Woodlands	Conroe	Texas
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Mercy Health Saint Mary's	Grand Rapids	Michigan
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Queen's Medical Center	Honolulu	Hawaii
United States	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	M D Anderson Cancer Center	Houston	Texas
United States	MD Anderson West Houston	Houston	Texas
United States	Providence Regional Cancer System-Lacey	Lacey	Washington
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Meharry Medical College	Nashville	Tennessee
United States	Providence Portland Medical Center	Portland	Oregon
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
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	Christus Saint Vincent Regional Cancer Center	Santa Fe	New Mexico
United States	Kaiser Permanente-Santa Rosa	Santa Rosa	California
United States	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina
United States	Kaiser Permanente-South San Francisco	South San Francisco	California
United States	Kaiser Permanente-Walnut Creek	Walnut Creek	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	9 Item Xerostomia Questionnaire	Self reported Xerostomia questionnaire completed prior to study randomization. Each item is scored on a scale of 0-10 with higher scores indicating greater dryness or discomfort due to dryness, yielding a total between 0 and 90.	Baseline to 4 weeks post acupuncture
Secondary	Duration of response to a maximum of 6 months	Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up.	Baseline to 6 Months