Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers

Inclusion criteria

Participants are eligible to be included in the study only if all the following criteria apply:

• 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).

Participants who have received prior induction chemotherapy or are planned for adjuvant chemotherapy are not excluded.

• Anatomically intact parotid and submandibular glands
• Eastern Cooperative Oncology Group performance status of 0 to 2
• Able to provide informed consent
• A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:

• Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the acupuncture period and for at least 28 days after the last acupuncture.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• 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.
• Local skin infections, lymphedema, or severe skin conditions (e.g., psoriasis, eczema) at or near the acupuncture sites
• Ongoing active systemic infection
• Current use of amifostine or cholinergic agonist medications (pilocarpine, cevimeline) that can affect salivary functions (salivary substitute not prohibited, but if using, they must refrain from using it for at least 24 hours prior to salivary flow assessment)
• Concurrent use of alternative medicines (e.g., Chinese Propriety medicines), that could affect salivary function
• Is pregnant or expecting to conceive within the projected duration of the trial, starting with the screening visit through 28 days after the last acupuncture treatment
• Low body mass index, ie. BMI < 15
• Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, may prevent the patient from cooperating with trial procedures