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.
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
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.
Single group
Acupuncture
Procedure/SurgeryStandardized techniques for point location will be utilized, based on anatomical landmarks as well as proportional measurements using the patient's own body. For example, finger breadth will be based on each patient's middle finger, and the proportional unit of measure, the "cun," is defined as the distance between the two medial ends of the creases of the interphalangeal joints when the middle finger is flexed. The selected body acupuncture points are tai xi (KI3), zhao hai (KI6), lie que (LU7), cheng jiang (CV24), he gu (LI4), yu ji (LU10). Ear acupuncture points are shen men (Shenmen), yan hou (Larynx), er zhong (Point Zero), nei fen mi (Salivary Gland 2'). Except for cheng jiang (CV24) that is located in the midline, all points will be treated bilaterally. Needles will be inserted in all acupuncture points at each visit.
The primary endpoint of our study is xerostomia score, measured using xerostomia questionnaire (XQ) 1 year post chemoradiotherapy.
Xerostomia will be assessed using a validated patient-reported xerostomia questionnaire (XQ), an 8-item questionnaire. Items are summed and transformed linearly to produce a summary score from 0 to 100, and a higher score represent more xerostomia.
Xerostomia score measuring using XQ post acupuncture (i.e. Week 10) and 6 months post chemoradiotherapy
Xerostomia will be assessed using a validated patient-reported xerostomia questionnaire (XQ), an 8-item questionnaire. Items are summed and transformed linearly to produce a summary score from 0 to 100, and a higher score represent more xerostomia.
Quality of life measured using Xerostomia Quality of Life Scale (XeQOLS) questionnaire at 6 months and 1 year post chemoradiotherapy
Quality of life score related to xerostomia will be measured using xerostomia quality of life scale questionnaire (XeQoLS).16 It measures the effects of salivary gland dysfunction and xerostomia on the 4 major domains of oral health-related quality of life: physical, pain, personal, and social, and it consists of 15 items, each rated on a 0-to-4 point Likert sale, with higher scores indicating more severe symptom burden.
Salivary flow rate measured at 6 months and 1 year post chemoradiotherapy
Adverse events graded using CTCAE version 5.0.
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