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

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ClinicalTrials.gov Identifier: NCT02589938
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 240 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 : November 11, 2012
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


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 Name: 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.

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 Name: Placebo acupuncture needle




Primary Outcome Measures :
  1. 9 Item Xerostomia Questionnaire [ Time Frame: 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 :
  1. Duration of response to a maximum of 6 months [ Time Frame: Baseline to 6 Months ]
    Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589938


Contacts
Contact: Tammy Vogler, RN 336-713-6907 tvogler@wakehealth.edu

Locations
United States, Hawaii
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Alyssa Hoekstra    808-564-5811    ahoekstra@cc.hawaii.edu   
United States, Illinois
Stroger Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Erika K Radeke    312-864-5204    eradeke@cookcountyhhs.org   
United States, Iowa
Iowa Wide Oncology Research Recruiting
Fairfield, Iowa, United States, 52556
Contact: Jeni Thompson    641-469-4144    jthompson@jeffersoncountyhealthcenter.org   
United States, Michigan
West Michigan NCORP - Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Janet Haworth    616-391-1230    janet.haworth@crcwm.org   
United States, Minnesota
Metro-Minnesota NCORP Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Rachel Fallon    952-993-1576    rachel.fallon@parknicollet.com   
United States, Missouri
Cancer Research of the Ozarks NCORP Recruiting
Springfield, Missouri, United States, 65807
Contact: Marilyn Bauer, BSN    417-269-4880    marilyn.bauer@coxhealth.com   
United States, New Mexico
New Mexico MU NCORP Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Kaylee Deutsch    505-925-0354    kdeutsch@nmcca.org   
Contact    505-925-0354      
United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Tammy Vogler, RN    336-713-6907    tvogler@wakehealth.edu   
United States, Tennessee
Baptist Health System/Mid-South Recruiting
Covington, Tennessee, United States, 38019
Contact: Toya Kimble    901-226-1491    toya.kimble@bmhcc.org   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vivien Lu, RN    713-745-4490    vhliu@mdanderson.org   
United States, Washington
Pacific Cancer Research Consortium Recruiting
Seattle, Washington, United States, 98122
Contact: Gina Lowry    503-215-6450    ginalowry@providence.org   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Suzanne C Danhauer, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02589938     History of Changes
Obsolete Identifiers: NCT01141231
Other Study ID Numbers: IRB00031366
REBAWF 97115 ( Other Identifier: NCI )
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Radiation Injuries
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries