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Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

Primary Purpose

Head And Neck Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Acupuncture - Group 1
Acupuncture - Group 2
Standard Care
Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head And Neck Cancer focused on measuring Radiation-induced xerostomia, Acupuncture, Oropharyngeal cancer, Radiation Therapy, IMRT, Dry mouth

Eligibility Criteria

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

Inclusion Criteria:

  1. 18 years of age and be able to give informed consent.
  2. Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.
  3. Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy).
  4. Anatomically intact parotid and submandibular glands.
  5. Karnofsky performance status > 60.

Exclusion Criteria:

  1. History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia.
  2. Prior head and neck radiation treatment.
  3. Suspected or confirmed physical closure of salivary gland ducts on either side.
  4. Known bleeding disorders or taking any dose of warfarin or heparin.
  5. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
  6. Local skin infections at or near the acupuncture sites or active systemic infection.
  7. History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
  8. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.
  9. Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria.
  10. Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine, cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function (see Appendix F).
  11. Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.

Sites / Locations

  • University of Texas MD Anderson Cancer Center
  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Acupuncture - Group 1

Acupuncture - Group 2

Standard Care

Arm Description

Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.

Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.

Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.

Outcomes

Primary Outcome Measures

Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)
Xerostomia Questionnaire (XQ), an 8-item questionnaire where subjects rate each symptom on an 11-point ordinal Likert scale from 0 to 10, with higher scores indicating greater dryness or discomfort due to dryness.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2010
Last Updated
September 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01266044
Brief Title
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
Official Title
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2011 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.
Detailed Description
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) into 1 of 3 groups. Group 1 will receive acupuncture during the radiation treatment period. Group 2 will receive acupuncture at different points on the body than those in Group 1 during the radiation treatment period. You will not know if you are assigned to Group 1 or 2. Group 3 will receive standard care without any kind of acupuncture during the radiation treatment period. Study Visits: If you are in Group 1 and 2, you will receive up to 21 acupuncture treatments with no more than 3 treatments per week during your regularly scheduled radiotherapy visits. It will take about 20 minutes to complete the acupuncture session each time. No matter which group you are assigned to, you will complete the following at the middle and end of radiotherapy treatment, and again 2-4, 5-9, 10-15 months after radiotherapy treatment is complete: Your vital signs will be recorded. You will be asked about any drugs you are taking. You will complete 9 questionnaires about your dry mouth, quality of life, and mood. It should take about 30 minutes in total to complete the questionnaires. If you are not able to complete the questionnaires during your regularly scheduled visits, you will be able to take the questionnaires home to complete them and will be given a postage-paid return envelope to mail them back to the study doctor. A saliva sample will be collected to measure the quality and amount of saliva produced during radiotherapy. You will complete a form about your oral hygiene that should take about 5 minutes to complete. Length of Study: You will remain on study for up to 17 months. Additional Information: After your participation on this study is complete and you are no longer enrolled in this study, if you were in Group 2 or 3, you will be offered to receive 3 acupuncture treatments. This is an investigational study. Up to 435 patients will take part in this multicenter study. Up to 193 will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head And Neck Cancer
Keywords
Radiation-induced xerostomia, Acupuncture, Oropharyngeal cancer, Radiation Therapy, IMRT, Dry mouth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
435 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture - Group 1
Arm Type
Experimental
Arm Description
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
Arm Title
Acupuncture - Group 2
Arm Type
Active Comparator
Arm Description
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
Arm Title
Standard Care
Arm Type
Other
Arm Description
Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture - Group 1
Intervention Description
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture - Group 2
Intervention Description
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard oral care recommendations. Participants in all groups will receive the same recommendations.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
Primary Outcome Measure Information:
Title
Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)
Description
Xerostomia Questionnaire (XQ), an 8-item questionnaire where subjects rate each symptom on an 11-point ordinal Likert scale from 0 to 10, with higher scores indicating greater dryness or discomfort due to dryness.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and be able to give informed consent. Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson. Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy). Anatomically intact parotid and submandibular glands. Karnofsky performance status > 60. Exclusion Criteria: History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia. Prior head and neck radiation treatment. Suspected or confirmed physical closure of salivary gland ducts on either side. Known bleeding disorders or taking any dose of warfarin or heparin. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory. Local skin infections at or near the acupuncture sites or active systemic infection. History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process. Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria. Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine, cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function (see Appendix F). Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Cohen, PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fudan University Cancer Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31808921
Citation
Garcia MK, Meng Z, Rosenthal DI, Shen Y, Chambers M, Yang P, Wei Q, Hu C, Wu C, Bei W, Prinsloo S, Chiang J, Lopez G, Cohen L. Effect of True and Sham Acupuncture on Radiation-Induced Xerostomia Among Patients With Head and Neck Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1916910. doi: 10.1001/jamanetworkopen.2019.16910.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

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