|Phase III||Supportive care||Active||Not specified||NCI, Other||2010-0547 MDA|
MDA-04-01, CDR0000674208, 2010-0547, NCT01141231
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
- To determine whether acupuncture can symptomatically improve moderate or severe radiation-induced xerostomia (grade 2 or 3) in patients with head and neck cancer.
- 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
- Diagnosis of head and neck cancer
- Xerostomia grade 2 or 3 due to prior bilateral radiotherapy
- Acupuncture naive
- 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
Trial Lead Organizations/Sponsors
M. D. Anderson Cancer Center at University of TexasNational Cancer Institute
|Lorenzo Cohen||Study Chair|
|Mark S. Chambers||Study Chair|
|CCOP Research Base Sites|
|MD Anderson Cancer Center CCOP Office||Ph: 713-563-0276|
|Joseph Chiang, MD||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01141231
ClinicalTrials.gov processed this data on November 20, 2013
Back to Top