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

This study is currently recruiting participants.
Verified November 2013 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: November 20, 2013
Last verified: November 2013

June 9, 2010
November 20, 2013
November 2012
November 2016   (final data collection date for primary outcome measure)
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.
Response to acupuncture intervention [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01141231 on ClinicalTrials.gov Archive Site
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.
Duration of response to a maximum of 12 weeks [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acupuncture in Treating Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer
A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • 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
Patients undergo acupuncture twice weekly for 4 weeks
  • 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.
    Intervention: Procedure: Acupuncture
  • Active Comparator: Acupuncture Group 2
    Acupuncture twice a week for 4 weeks and standard oral hygiene as in standard of care arm.
    Intervention: Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Not Provided
November 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01141231
2010-0547 MDA, MDA-04-01, CDR0000674208, 2010-0547
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Lorenzo Cohen, PhD M.D. Anderson Cancer Center
Study Chair: Mark S. Chambers, DMD, MS M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP