Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
Head And Neck Cancer
About this trial
This is an interventional prevention trial for Head And Neck Cancer focused on measuring Radiation-induced xerostomia, Acupuncture, Oropharyngeal cancer, Radiation Therapy, IMRT, Dry mouth
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and be able to give informed consent.
- Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.
- Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy).
- Anatomically intact parotid and submandibular glands.
- Karnofsky performance status > 60.
Exclusion Criteria:
- History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia.
- Prior head and neck radiation treatment.
- Suspected or confirmed physical closure of salivary gland ducts on either side.
- Known bleeding disorders or taking any dose of warfarin or heparin.
- Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
- Local skin infections at or near the acupuncture sites or active systemic infection.
- History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
- Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.
- Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria.
- Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine, cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function (see Appendix F).
- Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.
Sites / Locations
- University of Texas MD Anderson Cancer Center
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Other
Acupuncture - Group 1
Acupuncture - Group 2
Standard Care
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.