A Pilot Randomised Trial Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint of our study is xerostomia score, measured using xerostomia questionnaire (XQ) 1 year post chemoradiotherapy.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Arm 1: Early acupuncture arm
Patients in the early acupuncture arm will receive 10 sessions of weekly acupuncture, starting in the same week as CRT initiation.
干预措施: Acupuncture (Procedure)
Arm 2: Delayed acupuncture arm
Patient in the delayed acupuncture will receive 10 sessions of weekly acupuncture, starting 6 months (+/- 2 weeks) after the completion of CRT.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
The primary endpoint of our study is xerostomia score, measured using xerostomia questionnaire (XQ) 1 year post chemoradiotherapy.
时间窗: 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.
次要结局
- 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)