EFFECTIVENESS OF MARY D'UOL REPAIR BALM FOR PREVENTING AND / OR REDUCING TOXICITY SKIN IN PATIENTS WITH CANCER AND TREATMENT WITH ANY Antineoplastic Agent. RANDOM CLINICAL TRIAL.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Percentage of patients who develop dermatologic toxicity.
研究概览
简要总结
Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and purple) . The impact in patients' quality of life is great, so We had decided to conduct a randomized clinical trial to evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient treated with capecitabine .
Design: Randomized clinical trial phase II, in parallel and double-blind groups
Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will initiate treatment with capecitabine monotherapy.
Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary diagnosis, capecitabine monotherapy, sign the informed consent.
Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by a logistics regression model
详细描述
Intervention: Preventive treatment of dermatologic toxicities begin on the day of initiation of treatment with Xeloda, capecitabine + oxaliplatin, Adriamycin Liposomial or cytarabine
The product will be applied throughout the body in abundant quantities so that the skin is perfectly hydrated. It is applied twice daily (after showering and evening), gently massaging the area until completely absorbed.
The product will be provided at the unit of oncology pharmacy, when the patient is randomized. 3 packs per cycle will be provided. If not enough (because the patient has greater surface area) will be supplied more. Each time you start a new cycle 3 new packages will be delivered.
The patient will not apply any other cosmetic product in the treated areas.
In addition all patients regardless of the group will receive recommendations for reducing the appearance of skin problems caused by these type of drugs.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Over 18 years.
- •Sign the informed consent
排除标准
- •Patients with neoadjuvant treatment.
- •Patients with dermatologic diseases.
- •Patients treated with corticosteroids.
结局指标
主要结局
Percentage of patients who develop dermatologic toxicity.
时间窗: 3 moths
Compare the percentage of patients who develop dermatologic toxicity in any grade (1-5) between intervention and control group at three months of starting treatment, through CTCAE scale (National Cancer Institute Common Toxicity Criteria).
次要结局
- Percentaje of patients who have reduces skin toxicity(3 months)
- Need of pharmacological treatment to mitigate toxicity(3 months)
- Quality of life(3 months)
研究者
Patricia Seoane
oncologist physician
Basque Health Service