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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02589938

Collaborator

(none)

230

Enrollment

Locations

Arms

116.5

Actual Duration (Months)

6.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Radiation-Induced Xerostomia Head and Neck Cancer Radiation Toxicity Oral Complications of Chemotherapy and Head/Neck Radiation	Other: Standard Oral Hygiene Other: Standard Oral Hygiene + True Acupuncture Other: Standard Oral Hygiene + Sham Acupuncture	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 11, 2012

Actual Primary Completion Date :

Jul 29, 2022

Actual Study Completion Date :

Jul 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Oral Hygiene All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.	Other: Standard Oral Hygiene Oral hygiene care provided per individual institutions standard of care. Other Names: Oral Hygiene
Experimental: Standard Oral Hygiene + True Acupuncture All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes.	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 All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points.	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. Other Names: Placebo acupuncture needle

Arm

Intervention/Treatment

Active Comparator: Standard Oral Hygiene

Other: Standard Oral Hygiene

Oral hygiene care provided per individual institutions standard of care.

Other Names:

Oral Hygiene

Experimental: Standard Oral Hygiene + True Acupuncture

All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes.

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

All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points.

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.

Other Names:

Placebo acupuncture needle

Outcome Measures

Primary Outcome Measures

9 Item Xerostomia Questionnaire [Baseline to 4 weeks post acupuncture]
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.

Secondary Outcome Measures

Duration of response to a maximum of 6 months [Baseline to 6 Months]
Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California	United States	91505
2	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
3	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
4	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
5	Kaiser San Rafael-Gallinas	San Rafael	California	United States	94903
6	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
7	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
8	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
9	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
10	Queen's Medical Center	Honolulu	Hawaii	United States	96813
11	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
12	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
13	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612
14	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa	United States	52402
15	Saint Luke's Hospital	Cedar Rapids	Iowa	United States	52402
16	Mercy Health Saint Mary's	Grand Rapids	Michigan	United States	49503
17	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
18	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
19	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
20	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
21	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
22	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
23	Christus Saint Vincent Regional Cancer Center	Santa Fe	New Mexico	United States	87505
24	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
25	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
26	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio	United States	43214
27	Providence Portland Medical Center	Portland	Oregon	United States	97213
28	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	United States	29316
29	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
30	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
31	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
32	Meharry Medical College	Nashville	Tennessee	United States	37208
33	MD Anderson in The Woodlands	Conroe	Texas	United States	77384
34	M D Anderson Cancer Center	Houston	Texas	United States	77030
35	MD Anderson West Houston	Houston	Texas	United States	77079
36	Providence Regional Cancer System-Lacey	Lacey	Washington	United States	98503