About this trial
While existing data supports the use of acupuncture to reduce radiation-induced xerostomia, the optimal timing of acupuncture for managing chemoradiation-induced xerostomia remains an area of active investigation. Prior studies have administered acupuncture either in patients who developed xerostomia 12 months after radiation 10 or during the radiation therapy itself 9. The hypothesis is that acupuncture may be more effective in preventing and reducing xerostomia when administered early during CRT, rather than after chronic xerostomia has already set in. Yet, oncologists have concerns about the potentially higher risk of complications, such as infection, associated with acupuncture, especially if administered concurrently with chemoradiotherapy. Therefore, this study aims to conduct this randomised trial to evaluate the impact of early versus delayed acupuncture on patient-reported and objective measures of xerostomia, as well as the safety and tolerability of acupuncture in this setting.
To our knowledge, this will be the first randomised clinical trial evaluating the optimal timing for incorporating acupuncture to reduce xerostomia in patients undergoing chemoradiation for head and neck cancers. It is also the first study conducted in Singapore to study the role of acupuncture in reducing CRT-induced xerostomia.
Eligibility criteria
Qualifiers
Aged 21 years or older
Oral cavity or oropharyngeal squamous cell carcinoma, or nasopharyngeal carcinoma planned for either curative adjuvant or definitive chemoradiotherapy using intensity-modulated radiation therapy (IMRT).
Anatomically intact parotid and submandibular glands
Eastern Cooperative Oncology Group performance status of 0 to 2
Disqualifiers
History of xerostomia, Sjögren's disease, or another underlying systemic illness known to cause xerostomia
Prior head and neck radiation treatment
Has bleeding disorders (e.g. Hemophilia), or on anticoagulants (e.g. warfarin, low molecular weight heparin and novel oral anticoagulants)
Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
Trial design
Treatments tested in this trial
- Acupuncture
Treatment groups
Locations
1Sponsors and collaborators
National University Hospital, Singapore
Lead sponsor