Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel in the Prevention and Treatment of Radiation-induced Dermatitis in Patients With Head and Neck Cancer.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Time to development of G2 RID
研究概览
简要总结
Primary objective
- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.
Secondary objectives:
- To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.
- To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.
- To investigate safety and tolerability of Jalosome®.
- To investigate patient's compliance to Jalosome® treatment.
- To investigate patient's global satisfaction with Jalosome® treatment.
详细描述
Primary endpoint:
- Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance.
• Secondary endpoints:
- Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.
- Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
- Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms.
- RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms.
- Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms.
- Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.
- Patient's compliance to Jalosome® treatment.
- Patient's global satisfaction with Jalosome® treatment.
- Jalosome® overall safety and tolerability.
Study design:
Monocentric, randomized, double-blind, placebo controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female subject aged ≥18 years old.
- •Performance status 0-
- •Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
- •Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
- •Willingness and ability to give informed consent and comply with study procedures.
排除标准
- •Pregnant or lactating women.
- •Previous RT on the head and neck area.
- •Planned to receive concurrent cetuximab.
- •Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
- •Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
- •Use of a tissue-equivalent bolus.
- •Use of over-the-counter topical medications containing steroids.
- •Presence of rashes or unhealed wounds in the radiation field.
- •Recent sun exposure (<1 month).
- •Mental conditions that could adversely affect subject's adherence to the study.
研究组 & 干预措施
Group 1: Jalosome® Soothing gel
Jalosome® soothing gel ((L-Acetyl Carnitine chloridrate, Allantoin, Hydrogenated phosphatidylcholine, Sodium Hyaluronate) will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT.
Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT
干预措施: Jalosome® soothing gel (Device)
Group 2: Placebo
Placebo will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT.
Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT
干预措施: Placebo (Device)
结局指标
主要结局
Time to development of G2 RID
时间窗: 9 weeks
Mean number of days in development of G2 RID (according to CTCA), in the Jalosome® and placebo arms.
次要结局
- Subjects without G2 RID at different timepoints(9 weeks)
- Subjects without G2 RID at the end of RT(9 weeks)
- Worst skin toxicity(9 weeks)
- RID grade on the RISRAS(9 weeks)
- Compliance(9 weeks)
- Pain measured by NRS(9 weeks)
- PRO-Skindex-16 questionnaire score(9 weeks)
- Adverse events(9 weeks)