Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers
A Pilot Randomised Trial Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
June 29, 2026
May 1, 2026
3 years
May 19, 2026
June 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (4)
Xerostomia score measuring using XQ post acupuncture (i.e. Week 10) and 6 months post chemoradiotherapy
6 months
Quality of life measured using Xerostomia Quality of Life Scale (XeQOLS) questionnaire at 6 months and 1 year post chemoradiotherapy
1 year
Salivary flow rate measured at 6 months and 1 year post chemoradiotherapy
1 year
Adverse events graded using CTCAE version 5.0.
3 years
Study Arms (2)
Arm 1: Early acupuncture arm
EXPERIMENTALPatients in the early acupuncture arm will receive 10 sessions of weekly acupuncture, starting in the same week as CRT initiation.
Arm 2: Delayed acupuncture arm
ACTIVE COMPARATORPatient in the delayed acupuncture will receive 10 sessions of weekly acupuncture, starting 6 months (+/- 2 weeks) after the completion of CRT.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Haematology-Oncology, National University Hospital
Singapore, 119074, Singapore
Related Publications (2)
Lacas B, Carmel A, Landais C, Wong SJ, Licitra L, Tobias JS, Burtness B, Ghi MG, Cohen EEW, Grau C, Wolf G, Hitt R, Corvo R, Budach V, Kumar S, Laskar SG, Mazeron JJ, Zhong LP, Dobrowsky W, Ghadjar P, Fallai C, Zakotnik B, Sharma A, Bensadoun RJ, Ruo Redda MG, Racadot S, Fountzilas G, Brizel D, Rovea P, Argiris A, Nagy ZT, Lee JW, Fortpied C, Harris J, Bourhis J, Auperin A, Blanchard P, Pignon JP; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group. Radiother Oncol. 2021 Mar;156:281-293. doi: 10.1016/j.radonc.2021.01.013. Epub 2021 Jan 27.
PMID: 33515668BACKGROUNDZhou T, Huang W, Wang X, Zhang J, Zhou E, Tu Y, Zou J, Su K, Yi H, Yin S. Global burden of head and neck cancers from 1990 to 2019. iScience. 2024 Feb 20;27(3):109282. doi: 10.1016/j.isci.2024.109282. eCollection 2024 Mar 15.
PMID: 38455975BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wan Qin Chong
National University Hospital, Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2026
First Posted
June 29, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
June 29, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- They will be available beginning 3 months after Article publication with no end date.
- Access Criteria
- Other researchers should submit requests for access to the patient-level data to the corresponding author, including a proposal outlining their reasons for required data. Following a signed data access agreement, the data will be made available by a link sent from the corresponding author to the requester
Individual patient data will be available, including data dictionaries and all clinical data collected in the conduct of the trial, in a deidentified format. These will be available beginning 3 months after Article publication with no end date. other researchers should submit requests for access to the patient-level data to the corresponding author, including a proposal outlining their reasons for required data. Following a signed data access agreement, the data will be made available by a link sent from the corresponding author to the requester.