None listed
Conditions
Brief summary
Despite benefits of radiotherapy for head and neck cancer, oral sequelae occur, especially xerostomia, considered the most frequently, and potential debilitating side effect. Although extensively studied, treatment approaches including acupuncture therapy are considered primarily palliative, administered only after hyposalivation and xerostomia related symptoms is already present. The aim of this study was to investigate if the preventive acupuncture treatment (PAT), an innovative method using acupuncture before and during RT is effective in minimizing the severe radiation-induced xerostomia for patients with head and neck cancer.
Interventions
Patients submitted to radiotherapy (RT) with curative intend for head and neck cancer, receiving at least 5000 cGy irradiation total dose delivered to the bilateral area involving the major salivary glands. Patients will receive preventive acupuncture treatment (PAT), performed by the same clinician, twice a week, in a 2 - 3 weeks period before RT (4 - 6 sessions) and, in a 6 - 7 weeks period concomitantly with RT (12 – 14 sessions), totalizing 16 – 20 acupuncture sessions. The duration of each
Patients submitted to radiotherapy (RT) with curative intend for head and neck cancer, receiving at least 5000 cGy irradiation total dose delivered to the bilateral area involving the major salivary glands. Patients will receive preventive acupuncture treatment (PAT), performed by the same clinician, twice a week, in a 2 - 3 weeks period before RT (4 - 6 sessions) and, in a 6 - 7 weeks period concomitantly with RT (12 – 14 sessions), totalizing 16 – 20 acupuncture sessions. The duration of each acupuncture session is 20 minutes. The acupoints used at our protocol were selected according to traditional Chinese and occidental orthodox medicine’s principles, and it included local, distal and auricular points, named in accordance with the WHO Standard Acupuncture Nomenclature.
Sponsors
Sao Paulo University
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with head and neck malignancies requiring external beam RT, with planning of 5000 cGy or superior cumulative total doses delivered to the head and neck area involving the major salivary glands.
Exclusion criteria
Patients with history of salivary gland disorder; use of medication known to affect the function of the salivary glands.
Outcome results
None listed