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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Radiation Toxicity; Radiation-Induced Xerostomia; Oral Complications of Chemotherapy and Head/Neck Radiation
• Intervention / Treatment: Other: Standard Oral Hygiene; Other: Standard Oral Hygiene + True Acupuncture; Other: Standard Oral Hygiene + Sham Acupuncture

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 Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    • San Francisco, California, United States, 94115
      • Kaiser Permanente-San Francisco
    • San Jose, California, United States, 95119
      • Kaiser Permanente-Santa Teresa-San Jose
    • San Rafael, California, United States, 94903
      • Kaiser San Rafael-Gallinas
    • San Rafael, California, United States, 94903
      • Kaiser Permanente-San Rafael
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center - Santa Clara
    • Santa Rosa, California, United States, 95403
      • Kaiser Permanente-Santa Rosa
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente-South San Francisco
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente-Walnut Creek
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center
    • Honolulu, Hawaii, United States, 96817
      • The Cancer Center of Hawaii-Liliha
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr Hospital of Cook County
  • Iowa
    • Cedar Rapids, Iowa, United States, 52402
      • Saint Luke's Hospital
    • Cedar Rapids, Iowa, United States, 52402
      • Physicians' Clinic of Iowa PC
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health at Butterworth Campus
    • Grand Rapids, Michigan, United States, 49503
      • Mercy Health Saint Mary's
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic - Saint Louis Park
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Cancer Center
    • Santa Fe, New Mexico, United States, 87505
      • Christus Saint Vincent Regional Cancer Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Chillicothe, Ohio, United States, 45601
      • Adena Regional Medical Center
    • Columbus, Ohio, United States, 43214
      • Columbus Oncology and Hematology Associates Inc
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Prisma Health Cancer Institute - Spartanburg
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute - Eastside
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Greenville Memorial Hospital
    • Seneca, South Carolina, United States, 29672
      • Prisma Health Cancer Institute - Seneca
  • Tennessee
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College
  • Texas
    • Conroe, Texas, United States, 77384
      • MD Anderson in The Woodlands
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
    • Houston, Texas, United States, 77079
      • MD Anderson West Houston
  • Washington
    • Lacey, Washington, United States, 98503
      • Providence Regional Cancer System-Lacey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Suzanne C Danhauer, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2012
• Primary Completion (ACTUAL): July 29, 2022
• Study Completion (ACTUAL): July 29, 2022

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (ESTIMATE): October 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: radiation toxicity; xerostomia; oropharyngeal cancer; laryngeal cancer; hypopharyngeal cancer; lip and oral cavity cancer; nasopharyngeal cancer; paranasal sinus and nasal cavity cancer; salivary gland cancer; oral complications of radiation therapy; long-term effects of cancer treatment
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Head and Neck Neoplasms; Xerostomia
• Other Study ID Numbers: IRB00038707; REBAWF 97115 (OTHER: NCI); NCI-2011-02073 (REGISTRY: NCI CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
• IPD Sharing Time Frame: 6 months after publication for a 2 year duration
• IPD Sharing Access Criteria: upon request to NCORP@wakehealth.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No