Validation of the Improvement in the Management of Chemo-induced Mucositis in Hematology Through the Contribution of Photobiomodulation - The PHOTO-TREAT Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis
研究概览
简要总结
Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.
The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology).
详细描述
During this research, the investigators aim at validating the efficacy and impact of photo-biomodulation in the management of chemo-induced mucositis in hematology department of Strasbourg Cancer Institute (ICANS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adult patient;
- •Patients:
- •In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;
- •Signature of informed consent;
- •Patient registered with social security.
排除标准
- •Patient under guardianship or curatorship
- •Pregnant and breastfeeding woman
- •Allergy to polyurethanes
结局指标
主要结局
Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis
时间窗: Up to 12 weeks
Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria
次要结局
- Evaluate the impact of PBM in terms of reduction of the number of transfusions.(Up to 12 weeks)
- Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.(Up to 12 weeks)
- Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.(Up to 12 weeks)
- Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.(Up to 12 weeks)
- Evaluate the impact of PBM in terms of reduction of the length of hospital stay.(Up to 12 weeks)
- Evaluate the impact of PBM in terms of pain reduction(Up to 12 weeks)
- Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay(Up to 12 weeks)