Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

• ClinicalTrials.gov Identifier: NCT01266044
• Recruitment Status: Active, not recruiting
• First Posted: December 24, 2010
• Last Update Posted: April 28, 2022
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: December 22, 2010
• First Posted Date: December 24, 2010
• Last Update Posted Date: April 28, 2022
• Actual Study Start Date: December 9, 2011
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2010)

Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ) [ Time Frame: 4 weeks ]

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
• Official Title: Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Head And Neck Cancer

Intervention

• Procedure: Acupuncture - Group 1
  Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment.
• Procedure: Acupuncture - Group 2
  Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment.
• Other: Standard Care
  Standard oral care recommendations. Participants in all groups will receive the same recommendations.
• Other: Questionnaire
  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.

Study Arms

• Experimental: Acupuncture - Group 1
  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.
  Interventions:

  • Procedure: Acupuncture - Group 1
  • Other: Standard Care
  • Other: Questionnaire
• Active Comparator: Acupuncture - Group 2
  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.
  Interventions:

  • Procedure: Acupuncture - Group 2
  • Other: Standard Care
  • Other: Questionnaire
• Standard Care
  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.
  Interventions:

  • Other: Standard Care
  • Other: Questionnaire

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 5, 2015): 435
• Original Estimated Enrollment (submitted: December 22, 2010): 187
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, United States

Administrative Information

• NCT Number: NCT01266044
• Other Study ID Numbers: 2010-0584; NCI-2011-00306 ( Registry Identifier: NCI CTRP ); R01CA148707-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

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: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Lorenzo Cohen, PHD / Professor, UT MD Anderson Cancer Center
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Lorenzo Cohen, PHD; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: April 2022