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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 October 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: October 21, 2014
Last verified: October 2014

June 9, 2010
October 21, 2014
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)

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.
Both
18 Years and older
No
United States
 
NCT01141231
2010-0547 MDA, MDA-04-01, CDR0000674208, 2010-0547, NCI-2011-02073, U10
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
October 2014

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