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

NCT ID: NCT02589938

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-29
• Study Completion Date: 2022-07-29

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Oral Hygiene

Intervention Type: OTHER

Oral hygiene care provided per individual institutions standard of care.

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.

Group Type: EXPERIMENTAL

Standard Oral Hygiene + True Acupuncture

Intervention Type: OTHER

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

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.

Group Type: OTHER

Standard Oral Hygiene + Sham Acupuncture

Intervention Type: OTHER

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.

Interventions

Standard Oral Hygiene

Oral hygiene care provided per individual institutions standard of care.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Oral Hygiene; Placebo acupuncture needle

Eligibility Criteria

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 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.

• 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.

Exclusion Criteria

• History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne C Danhauer, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Meharry Medical College

Nashville, Tennessee, United States

MD Anderson in The Woodlands

Conroe, Texas, 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

Countries

United States

References

Cohen L, Danhauer SC, Garcia MK, Dressler EV, Rosenthal DI, Chambers MS, Cusimano A, Brown WM, Ochoa JM, Yang P, Chiang JS, Gordon O, Crutcher R, Kim JK, Russin MP, Lukenbill J, Porosnicu M, Yost KJ, Weaver KE, Lesser GJ. Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer: A Multicenter Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410421. doi: 10.1001/jamanetworkopen.2024.10421.

Reference Type: DERIVED

PMID: 38739392 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

REBAWF 97115

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-02073

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB00038707

Identifier Type: -

Identifier Source: org_study_id

NCT01141231

Identifier Type: -

Identifier Source: nct_alias