Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients. Real World Setting Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Oral mucositis grade in patients during chemotherapy and radiotherapy treatments
研究概览
简要总结
Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to nutritive deficiency. Oral mucositis causes secondary infections, increased hospital stay, whereas pain syndrome results in an emotional distress, anorexia and disables natural feeding.
详细描述
Primary:
To evaluate the efficacy of ONCOXIN on oral mucositis symptoms in patients who receive chemotherapy and/or radiotherapy.
Secondary:
To evaluate the effects of ONCOXIN on nutritional status in patients who receive chemotherapy and/or radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed and dated informed consent form;
- •Patients of both genders, aged 45-75;
- •Malignant neoplasms which have radio-, chemotherapy or their combinations prescribed;
- •WHO oral toxicity scale grade 2 - 3.
排除标准
- •Significant, according to the investigator judgement, concomitant diseases or states which make it complicate or even impossible the patient's participation in the study or make it difficult to interpret the clinical data obtained in any stage of the study always including the following:
- •Mental disorders;
- •Serious/chronic infectious and parasitic diseases;
- •Intolerability to any of ONCOXIN components.
- •Relations with study center personnel (study center staff or family member of the investigator, coordinator or assistant).
- •If the patient fails to assess his/her physical and emotional condition;
- •If the patient fails to comply with the requirements;
- •Patient's refusal to participate in the study;
- •Pregnancy or lactation.
研究组 & 干预措施
Oncoxin®
Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN
干预措施: Oncoxin® (Dietary Supplement)
No Oncoxin Treatment®
Chemo-, radiotherapy or their combination + standard oral mucositis treatment.
结局指标
主要结局
Oral mucositis grade in patients during chemotherapy and radiotherapy treatments
时间窗: 21 days
Efficacy of OCOXIN on oral mucositis symptoms in patients who receive chemotherapy and/or radiotherapy with WHO oral toxicity scale grades. The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis. WHO Oral Mucositis Grading Scale: * 0 (none): None * I (mild): Oral soreness, erythema * II (moderate): Oral erythema, ulcers, solid diet tolerated * III (severe): Oral ulcers, liquid diet only * IV (life-threatening): Oral alimentation impossible
次要结局
- Nutritional status of the patients during Chemotherapy and radiotherapy treatments related with weight gain(21 days)
- Nutritional status of the patients during Chemotherapy and radiotherapy treatments(21 days)