Feasibility of an RCT to Investigate the Efficacy of Ice Plant Intensive Cream for the Prevention of Hand-foot Syndrome in Patients With Breast Cancer Receiving Therapy With Doxorubicin and/or Docetaxel: Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of days in which the intervention was carried out per protocol
研究概览
简要总结
The present pilot study investigates the feasibility of a prospective larger confirmatory study on the efficacy of Dr. Hauschka Med Ice Plant Intensive Cream for the prevention of hand-foot syndrome in patients with breast carcinoma undergoing therapy with doxorubicin and / or docetaxel.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients
- •Therapy with Doxorubicin and/or Docetaxel
- •Karnofsky performance status scale > 80
- •Informed consent
排除标准
- •Patients with previous skin disease and/or polyneuropathy
- •Intolerance or allergic reaction on at least one ingredient of Ice Plant Intensive Cream
- •Already receiving chemotherapy
- •Usage of Ice Plant Intensive Cream before trial
- •Severe physical or psychological illness due to which the patient is not able to participate in the study
- •Lack of German language skills
研究组 & 干预措施
Ice Plant Intensive Cream plus Standard Care
This group receives a 30-minute nursing consultation on the standard treatment and on the use of the Ice Plant Intensive Cream for the prevention of hand-foot syndrome.
干预措施: Ice Plant Intensive Cream plus Standard Care (Other)
Standard Care
This group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome.
干预措施: Standard Care (Other)
结局指标
主要结局
Number of days in which the intervention was carried out per protocol
时间窗: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
The number of days in which the intervention was carried out and how often per day the intervention was carried out will be collected daily in a diary. The number of days in which the intervention was carried out will be assessed.
Number of patients that can be recruited in a 9 months time period
时间窗: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
The number of patients that can be recruited in a 9 months time period will be recorded in the study center
Proportion of potentially eligible patients that agree to participate in the study and thus to randomization
时间窗: 7 days after last chemotherapy cycle (each cycle 3-4 weeks )
The proportion of potentially eligible patients that agree to participate in the study and thus to randomization will be recorded in the study center
Proportion of randomized patients who leave the study early
时间窗: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
The proportion of randomized patients who leave the study early will be recorded in the study center
Number of days in which the symptom diary was completed correctly
时间窗: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
Symptoms will be collected daily in a symptom diary. The completeness of each patient diary will be assessed.
次要结局
- Pain in hands and feet(From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks))
- Prevention of the hand-foot syndrome(From the start of chemotherapy to 7 days after the last chemotherapy cycle (daily diary) (each cycle is 3-4 weeks))
- Severity of the hand-foot syndrome(From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks))
- Sensory disturbances in the hands and feet(From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks))
- Impairment of daily life due to the changes in the hands and feet(From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks))
- Dermatology Life Quality Index (DLQI) questionnaire(7 days after the last chemotherapy cycle "through study completion, an average of 1 year".(each cycle is 3-4 weeks))
- Dermatology Life Quality Index (DLQI) questionnaire(7 days after the first chemotherapy cycle (each cycle is 3-4 weeks))
- Dermatology Life Quality Index (DLQI) questionnaire(7 days after the third chemotherapy cycle (each cycle is 3-4 weeks))