A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
N/A
N/A
Both
Head and Neck Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Oral Complications of Chemotherapy and Head/Neck Radiation, Radiation Toxicity, Xerostomia
Trial Information
A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia 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
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Response to acupuncture intervention
Outcome Description:
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.
Outcome Time Frame:
Baseline to 4 weeks post acupuncture
Safety Issue:
No
Principal Investigator
Lorenzo Cohen, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2010-0547 MDA
NCT ID:
NCT01141231
Start Date:
November 2012
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Long-term Effects Secondary to Cancer Therapy in Adults
- Oral Complications of Chemotherapy and Head/Neck Radiation
- Radiation Toxicity
- Xerostomia
- 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
- Head and Neck Neoplasms
- Xerostomia
- Radiation Injuries
Name | Location |
|---|---|
| CCOP Research Base Sites | Houston, Texas 77030 |
