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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01141231
First received: June 9, 2010
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Oral Complications of Chemotherapy and Head/Neck Radiation
Radiation Toxicity
Xerostomia
Procedure: Acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response to acupuncture intervention [ Time Frame: Baseline to 4 weeks post acupuncture ] [ Designated as safety issue: No ]
    Xerostomia Questionnaire score before and 4 weeks after starting acupuncture. The Xerostomia Questionnaire is an 8-item survey with each item scored between 0 and 10 then the final score normalized to a 0-100 scale. High score of 10 = increased severity of xerostomia.


Secondary Outcome Measures:
  • Duration of response to a maximum of 6 months [ Time Frame: Baseline to 6 Months ] [ Designated as safety issue: No ]
    Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up.


Estimated Enrollment: 240
Study Start Date: November 2012
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
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.
Active Comparator: Acupuncture Group 1
Acupuncture at 3 sites on each ear, on the chin, on each forearm, and on each leg twice a week for 4 weeks; and standard oral hygiene as in standard of care arm.
Procedure: Acupuncture
Patients undergo acupuncture twice weekly for 4 weeks
Active Comparator: Acupuncture Group 2
Acupuncture twice a week for 4 weeks and standard oral hygiene as in standard of care arm.
Procedure: Acupuncture
Patients undergo acupuncture twice weekly for 4 weeks

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of head and neck cancer
  • Xerostomia grade 2 or 3 due to prior bilateral radiotherapy
  • Acupuncture naive

PATIENT CHARACTERISTICS:

  • No prior xerostomia
  • No infection at or near the acupuncture sites OR active infection
  • Ability to speak, read, and understand English

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 9 months since prior radiotherapy
  • Chemotherapy during or after radiotherapy allowed
  • No concurrent or plan to receive another xerostomia treatment agent

    • At least 14 days since prior agents known to treat xerostomia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141231

Locations
United States, Texas
CCOP Research Base Sites Recruiting
Houston, Texas, United States, 77030
Contact: MD Anderson Cancer Center CCOP Office    713-563-0276      
Principal Investigator: Joseph Chiang, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Lorenzo Cohen, PhD M.D. Anderson Cancer Center
Study Chair: Mark S. Chambers, DMD, MS M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01141231     History of Changes
Other Study ID Numbers: 2010-0547 MDA, MDA-04-01, CDR0000674208, 2010-0547, NCI-2011-02073
Study First Received: June 9, 2010
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
salivary gland cancer
radiation toxicity
xerostomia
long-term effects of cancer treatment
oral complications of radiation therapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Radiation Injuries
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014