Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Phase II Randomized Study in Patients With Upper Aerodigestive Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline
研究概览
简要总结
Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy.
Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment.
The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days.
Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy
- •Patients with a grade 2 mucositis (according to the NCI CTCAE version 5.0) appearing during treatment.
- •Patients available to perform the LLLT treatment: 5 visits at 3 days intervals
- •Patients must provide written informed consent prior to any study specific procedures.
- •Patients affiliated to a Social Health Insurance in France.
排除标准
- •Patients who have already received a cervicofacial radiotherapy
- •Patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer
- •Patients under targeted therapy for their upper aero-digestive tract cancer
- •Patients under systemic corticotherapy
- •Patients with a non-grade 2 mucositis (according to the NCI CTCAE version 5.0)
- •Patients with ulceration or any other oral mucosa pathology than mucositis
- •Pregnant or breastfeeding women
- •Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
结局指标
主要结局
Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline
时间窗: 16 days for each patient
次要结局
- Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores(16 days for each patient)
- Frequency of adverse events related to the LLLT using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 5.0(16 days for each patient)
- Quality of Life assessed by the Quality of Life Questionnaire specific to Head and Neck cancer (H&N35)(16 days for each patient)