Head Cancer, Nasopharyngeal Carcinoma (NPC), Neck Cancer, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Xerostomia
Conditions
Keywords
Acupuncture
Brief summary
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.
Interventions
PROCEDUREAcupuncture
Standardized 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.
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply: 1. Aged 21 years or older 2. 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. 3. Anatomically intact parotid and submandibular glands 4. Eastern Cooperative Oncology Group performance status of 0 to 2 5. Able to provide informed consent 6. 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: 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR 2. 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: 1. History of xerostomia, Sjögren's disease, or another underlying systemic illness known to cause xerostomia 2. Prior head and neck radiation treatment 3. Has bleeding disorders (e.g. Hemophilia), or on anticoagulants (e.g. warfarin, low molecular weight heparin and novel oral anticoagulants) 4. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory. 5. Local skin infections, lymphedema, or severe skin conditions (e.g., psoriasis, eczema) at or near the acupuncture sites 6. Ongoing active systemic infection 7. 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) 8. Concurrent use of alternative medicines (e.g., Chinese Propriety medicines), that could affect salivary function 9. 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 10. Low body mass index, ie. BMI \< 15 11. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, may prevent the patient from cooperating with trial procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint of our study is xerostomia score, measured using xerostomia questionnaire (XQ) 1 year post chemoradiotherapy. | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Xerostomia score measuring using XQ post acupuncture (i.e. Week 10) and 6 months post chemoradiotherapy | 6 months | 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 | 1 year | 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 | 1 year | — |
| Adverse events graded using CTCAE version 5.0. | 3 years | — |
Countries
Singapore
Contacts
CONTACTWan Qin Chong
PRINCIPAL_INVESTIGATORWan Qin Chong
National University Hospital, Singapore
Outcome results
None listed