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XerostomiaNCT07674706

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

A study testing Acupuncture in people with Xerostomia and Head Cancer, run by National University Hospital, Singapore at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Xerostomia, Head Cancer, Neck Cancer
What is being tested?
Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSingapore
Study dates
Jun 2026to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wan Qin Chong contact

+65 6772 5200

wan_qin_chong@nuhs.edu.sg

Singapore1 site

  • Department of Haematology-Oncology, National University Hospital

    Singapore, 119074

    Wan Qin Chong, +65 6772 5200, wan_qin_chong@nuhs.edu.sg

Other trials in Singapore

About this study

Official title: A Pilot Randomised Trial Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers

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.

Being tested
Acupuncture
Keywords
Acupuncture
Medical subject headings
Xerostomia, Head and Neck Neoplasms, Nasopharyngeal Carcinoma, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    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.

Study groups in NCT07674706
Study groupRoleWhat they receive
Arm 1: Early acupuncture armExperimentalPatients in the early acupuncture arm will receive 10 sessions of weekly acupuncture, starting in the same week as CRT initiation.
Receives: Procedure: Acupuncture
Arm 2: Delayed acupuncture armActive comparatorPatient in the delayed acupuncture will receive 10 sessions of weekly acupuncture, starting 6 months (+/- 2 weeks) after the completion of CRT.
Receives: Procedure: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (4)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 1 year

  3. Salivary flow rate measured at 6 months and 1 year post chemoradiotherapy

    Measured: 1 year

  4. Adverse events graded using CTCAE version 5.0.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07674706
Sponsor's protocol ID
2025-0590
Status last verified
May 2026
First submitted
19 May 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 33515668

  • Zhou 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.

    PubMed 38455975

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Xerostomia and Head Cancer, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wan Qin Chong (+65 6772 5200, wan_qin_chong@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint of our study is xerostomia score, measured using xerostomia questionnaire (XQ) 1 year post chemoradiotherapy. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07674706, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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