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Clinical Trials (PDQ®)

Acupuncture in Treating Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careActiveNot specifiedNCI, Other2010-0547 MDA
MDA-04-01, CDR0000674208, 2010-0547, NCI-2011-02073, U10, NCT01141231

Trial Description

Summary

RATIONALE: Acupuncture may help relieve dry mouth caused by radiation therapy.

PURPOSE: This randomized phase III trial is studying to see how well one set of acupuncture points work in comparison to a different set of acupuncture points or standard therapy in treating dry mouth caused by radiation therapy in patients with head and neck cancer.

Further Study Information

OBJECTIVES:

Primary

  • To determine whether acupuncture can symptomatically improve moderate or severe radiation-induced xerostomia (grade 2 or 3) in patients with head and neck cancer.

Secondary

  • To explore the duration of response (up to a maximum of 6 months) in the subgroup of patients who report a response to the acupuncture intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease, age, sex, the mean of parotid radiotherapy doses received, and baseline Xerostomia Questionnaire (XQ) scores. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.
  • Arm II: Patients receive acupuncture at 3 sites on each ear, on the chin, on each forearm, and on each leg twice a week for 4 weeks. Patients with minor response may continue treatment for an additional 4 weeks. Patients also receive standard oral hygiene as in arm 1.
  • Arm III: Patients receive acupuncture twice a week for 4 weeks and standard oral hygiene as in arm 1. Patients with minor response may continue treatment for an additional 4 weeks.

Patients complete XQ, the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), and the Functional Assessment of Cancer Therapy (FACT-G) questionnaires at baseline and at the end of weeks 4, 8, and12. Patients with partial response or minor response, according to week-8 questionnaires, complete XQ, MDASI-HN, and the FACT-G at the end of week 12 and at 6 months. Patients in group 2 and 3 also complete the Acupuncture Expectancy Scale (AES). Saliva is also collected at these time points.

  • Coordinating Center: The University of Texas MD Anderson Cancer Center Community Clinical Oncology Program (CCOP) Research Base

Eligibility Criteria

Inclusion Criteria:

1. Must be at least 18 years of age and able to give informed consent.

2. Must have a diagnosis of head/neck cancer.

3. Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to RTOG scale: Grade 0 - None Grade 1 - Slight dryness of mouth, good response on stimulation Grade 2 - Moderate dryness of mouth, poor response on stimulation Grade 3 - Complete dryness of mouth, no response on stimulation Grade 4 - Fibrosis

4. Must have received external beam radiation at a mean dose of at least 25 Gy to one of the parotid glands. The other gland can receive less than 25 Gy. (Chemotherapy during or subsequent to radiation therapy is allowed).

5. Must have completed radiotherapy at least 12 months prior to entry. Note: Patients currently receiving radiation therapy not involving radiation to the head and neck may be eligible to participate in this trial.

6. Must have anatomically intact parotid and submandibular glands.

7. Must be acupuncture naïve.

8. Must not have any history of xerostomia prior to radiation therapy.

9. No active infection.

10. Must have Karnofsky performance status >/= 60 or ECOG performance status of 0-2.

Exclusion Criteria:

1. History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.

2. Suspected or confirmed closure of salivary gland ducts on either side.

3. Currently receiving or planning to receive other xerostomia treatment, including drugs, herbs or devices. All other treatments known to affect salivation should be stopped at least 14 days prior to enrollment.

4. Have received any investigational new drug within the past 30 days or planning to receive such during the study period.

5. Previous acupuncture treatment.

6. Active systemic infection or skin infection at or near the acupuncture sites.

7. History of xerostomia prior to the head/neck radiation therapy.

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

National Cancer Institute

Lorenzo CohenStudy Chair

Mark S. ChambersStudy Chair

Trial Sites

U.S.A.
Texas
  Houston
 CCOP Research Base Sites
 MD Anderson Cancer Center CCOP Office Ph: 713-563-0276
 Joseph Chiang, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01141231
ClinicalTrials.gov processed this data on October 22, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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