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

Official title

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

Overview

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

• Procedure Acupuncture
  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)

Primary outcome measures

• The primary endpoint of our study is xerostomia score, measured using xerostomia questionnaire (XQ) 1 year post chemoradiotherapy. [Time frame: 1 year]

Secondary outcome measures (4)

• Xerostomia score measuring using XQ post acupuncture (i.e. Week 10) and 6 months post chemoradiotherapy [Time frame: 6 months]
• Quality of life measured using Xerostomia Quality of Life Scale (XeQOLS) questionnaire at 6 months and 1 year post chemoradiotherapy [Time frame: 1 year]
• Salivary flow rate measured at 6 months and 1 year post chemoradiotherapy [Time frame: 1 year]
• Adverse events graded using CTCAE version 5.0. [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Singapore · 1 center

• Department of Haematology-Oncology, National University Hospital — Singapore

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; PMID 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. PMID 38455975

Identifiers

NCT: NCT07674706 · 2025-0590

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗