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Trial record 1 of 1 for:    radiation-induced xerostomia wake forest
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Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer (ACUPUNCTURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02589938
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE August 17, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE November 11, 2012
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
9 Item Xerostomia Questionnaire [ Time Frame: Baseline ]
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.
Change History Complete list of historical versions of study NCT02589938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
Official Title  ICMJE A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Radiation-Induced Xerostomia
  • Head and Neck Cancer
  • Radiation Toxicity
  • Oral Complications of Chemotherapy and Head/Neck Radiation
Intervention  ICMJE
  • Other: Standard Oral Hygiene
    Oral hygiene care provided per individual institutions standard of care.
    Other Name: Oral Hygiene
  • 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
    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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Standard 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.

    Intervention: Other: Standard Oral Hygiene + True Acupuncture
  • 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.

    Intervention: Other: Standard Oral Hygiene + Sham Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Craver 336-716-0891 NCORP@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02589938
Other Study ID Numbers  ICMJE IRB00031366
REBAWF 97115 ( Other Identifier: NCI )
NCI-2011-02073 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Time Frame: 6 months after publication for a 2 year duration
Access Criteria: upon request to NCORP@wakehealth.edu
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzanne C Danhauer, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP