A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 12
- 主要终点
- To evaluate the efficacy of preventive and curative low energy laser induced mucositis in patients receiving concomitant chemotherapy and radiotherapy for squamous cell carcinoma of the head and neck with stage III-IV
研究概览
简要总结
The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.
详细描述
This is a Phase III randomized, double-blind, multicenter study, with two groups of patients receiving radiotherapy and concomitant chemotherapy.
The patients will be randomized as follows: Arm A = patients will receive a preventive and curative treatment by low-energy laser, and arm B = a control group treated with standard local treatments and a placebo laser (laser nonfunctional).
Randomization will be balanced in a ratio 1: 1 and stratified by the investigator site. Assessments of mucositis, nutritional status, tolerance of the laser and pain will be performed throughout the treatment, once a week, by an investigator unaware of the patients treatment arm. The locoregional control will be evaluated every 3 months during the first year, then every 6 months up to 5 years. In case of progression, treatments undertaken and their results should be reported.
Radiotherapy: All patients will be treated with conformal radiotherapy with or without IMRT. The dose should be adapted to the treatment indication (exclusive or postoperative) and the histological findings in case of tumoral resection.
The radiotherapy will be prescribed in accordance with the recommendations of the ICRU 50 report. The dose delivered will always be 2 Gy per day 5 times a week. All beams will be treated in each session. A radiological audit will be conducted for each beam treated by photons in the first session and at least once a week.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed
- •PS > or = 2
- •Estimated life expectancy greater than 3 months in the absence of treatment
- •Concomitant chemotherapy with one of the following choices not prohibited:
- •Cetuximab alone
- •5-FU combined to Carboplatin or Cisplatin
- •Cisplatin alone Being defined as follows: serum creatinine < 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the Cockcroft method) in case of serum creatinine > 120 µmol/l
- •Appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results:
- •Hemoglobin> 8g/dL
- •Neutrophils> 1500 x 109 / L
- •Platelets> 100 x 109 / l
- •Total bilirubin <1.5 times the upper limit of normal
- •ALT / AST and alkaline phosphatase <2.5 times the upper limit of normal.
- •For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required.
排除标准
- •Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix
- •Neoadjuvant chemotherapy
- •Metastatic disease
- •Previous treatment with ENT radiotherapy
- •Severe hypersensitivity known to platinum based agent
- •Any uncontrolled pathology (respiratory, cardiac, hepatic or renal)
- •Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
研究组 & 干预措施
laser low-level energy functional
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
干预措施: low level laser therapy (Procedure)
laser low-level energy nonfunctional
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
干预措施: placebo (laser low level energy nonfunctional) (Procedure)
结局指标
主要结局
To evaluate the efficacy of preventive and curative low energy laser induced mucositis in patients receiving concomitant chemotherapy and radiotherapy for squamous cell carcinoma of the head and neck with stage III-IV
时间窗: 7 weeks
Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification
时间窗: Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment
The primary outcome is the number of patients with oral mucositis grade ≥2 as assessed by the World Health Organization (WHO) oral mucositis grading scale, reflecting functional impairment in oral intake. Oral mucositis is assessed weekly to evaluate the preventive and therapeutic efficacy of low-level laser therapy in patients undergoing concomitant radiotherapy and chemotherapy for stage III-IV head and neck squamous cell carcinoma.
次要结局
- To assess the laser tolerance(7 weeks)
- To evaluate the pain by a numerical analog, in its the nature and the dosage of analgesics consumed.(7 weeks)
- To assess the nutritional status by body weight follow-up and the capability of swallowing various foods, and biologically the serum albumin, prealbumin, and optionally a measure of body fat (impedance, skinfolds)(7 weeks)
- To assess the quality of life using the QLQ-HN35 questionnaire.(7 weeks)
- To assess the treatment compliance by the spread and discontinuation of radiation therapy, in duration (days) and the cause of discontinuations, the number of cycles of chemotherapy administered, and dose modifications or possible delays.(7 weeks)
- Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)(Assessment at Week 7, corresponding to the completion of concomitant chemoradiotherapy.)