Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

NCT01266044 | Active Not Recruiting Phase 3

• 3 other identifiers: 2010-0584NCI-2011-00306R01CA148707-01A1
• Study Type: interventional
• Target: 435
• Locations: 2 countries
• Sites: 2

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.

Conditions

Head And Neck Cancer

Keywords

Radiation-induced xerostomia; Acupuncture; Oropharyngeal cancer; Radiation Therapy; IMRT; Dry mouth

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (3)

Acupuncture - Group 1

EXPERIMENTAL

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.

Procedure: Acupuncture - Group 1; Other: Standard Care; Other: Questionnaire

Acupuncture - Group 2

ACTIVE COMPARATOR

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.

Procedure: Acupuncture - Group 2; Other: Standard Care; Other: Questionnaire

Standard Care

OTHER

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.

Other: Standard Care; Other: Questionnaire

Interventions

Acupuncture - Group 1 PROCEDURE

Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment.

Acupuncture - Group 1

Acupuncture - Group 2 PROCEDURE

Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment.

Acupuncture - Group 2

Standard Care OTHER

Standard oral care recommendations. Participants in all groups will receive the same recommendations.

Acupuncture - Group 1; Acupuncture - Group 2; Standard Care

Questionnaire OTHER

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 - Group 1; Acupuncture - Group 2; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fudan University Cancer Hospital

Shanghai, China

Location

Related Publications (2)

• Ratcliff CG, Ahn A, Custodio AL, Garcia MK, Meng Z, Rosenthal DI, Shen Y, Chambers MS, Hu C, Cohen L. The differential effects of social support on quality of life in head and neck cancer patients in the United States and China. Eur J Oncol Nurs. 2026 Feb 20;81:103156. doi: 10.1016/j.ejon.2026.103156. Online ahead of print.

  PMID: 41723882 DERIVED

• 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.

  PMID: 31808921 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms; Xerostomia

Interventions

Standard of Care; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Salivary Gland Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Lorenzo Cohen, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 24, 2010
• Study Start: December 9, 2011
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1); CN (1)