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

Primary Purpose

Radiation-Induced Xerostomia, Head and Neck Cancer, Radiation Toxicity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Oral Hygiene
Standard Oral Hygiene + True Acupuncture
Standard Oral Hygiene + Sham Acupuncture
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Radiation-Induced Xerostomia focused on measuring hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, salivary gland cancer, radiation toxicity, xerostomia, long-term effects of cancer treatment, oral complications of radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Kaiser Permanente-San Francisco
  • Kaiser Permanente-Santa Teresa-San Jose
  • Kaiser Permanente-San Rafael
  • Kaiser San Rafael-Gallinas
  • Kaiser Permanente Medical Center - Santa Clara
  • Kaiser Permanente-Santa Rosa
  • Kaiser Permanente-South San Francisco
  • Kaiser Permanente-Walnut Creek
  • Queen's Medical Center
  • University of Hawaii Cancer Center
  • The Cancer Center of Hawaii-Liliha
  • John H Stroger Jr Hospital of Cook County
  • Physicians' Clinic of Iowa PC
  • Saint Luke's Hospital
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • Mercy Hospital
  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • Park Nicollet Clinic - Saint Louis Park
  • University of New Mexico Cancer Center
  • Christus Saint Vincent Regional Cancer Center
  • Wake Forest University Health Sciences
  • Adena Regional Medical Center
  • Columbus Oncology and Hematology Associates Inc
  • Providence Portland Medical Center
  • Prisma Health Cancer Institute - Spartanburg
  • Prisma Health Greenville Memorial Hospital
  • Prisma Health Cancer Institute - Eastside
  • Prisma Health Cancer Institute - Seneca
  • Meharry Medical College
  • MD Anderson in The Woodlands
  • M D Anderson Cancer Center
  • MD Anderson West Houston
  • Providence Regional Cancer System-Lacey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Standard Oral Hygiene

Standard Oral Hygiene + True Acupuncture

Standard Oral Hygiene + Sham Acupuncture

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 17, 2015
Last Updated
November 1, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02589938
Brief Title
Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
Acronym
ACUPUNCTURE
Official Title
A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2012 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-Induced Xerostomia, Head and Neck Cancer, Radiation Toxicity, Oral Complications of Chemotherapy and Head/Neck Radiation
Keywords
hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, salivary gland cancer, radiation toxicity, xerostomia, long-term effects of cancer treatment, oral complications of radiation therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Oral Hygiene
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Oral Hygiene + True Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Oral Hygiene + Sham Acupuncture
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Oral Hygiene
Other Intervention Name(s)
Oral Hygiene
Intervention Description
Oral hygiene care provided per individual institutions standard of care.
Intervention Type
Other
Intervention Name(s)
Standard Oral Hygiene + True Acupuncture
Intervention Description
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
Intervention Name(s)
Standard Oral Hygiene + Sham Acupuncture
Other Intervention Name(s)
Placebo acupuncture needle
Intervention Description
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.
Primary Outcome Measure Information:
Title
9 Item Xerostomia Questionnaire
Description
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.
Time Frame
Baseline to 4 weeks post acupuncture
Secondary Outcome Measure Information:
Title
Duration of response to a maximum of 6 months
Description
Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up.
Time Frame
Baseline to 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne C Danhauer, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Kaiser Permanente-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente-Santa Teresa-San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente-San Rafael
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser San Rafael-Gallinas
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente-Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Kaiser Permanente-South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente-Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Physicians' Clinic of Iowa PC
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Saint Luke's Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Christus Saint Vincent Regional Cancer Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Columbus Oncology and Hematology Associates Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Prisma Health Cancer Institute - Spartanburg
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
MD Anderson in The Woodlands
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson West Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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