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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
36
This group receives a 30-minute nursing consultation on the standard treatment according to the guideline "Supportive Therapy" for hand-foot syndrome and on the use of the Ice Plant Intensive Cream for the prevention of hand-foot syndrome. The nursing consultation on the standard treatment includes recommended basic measures for the prophylaxis of hand-foot syndrome such as the avoidance of mechanical stress and chemical irritants. In addition, treatment of pre-existing skin conditions is recommended. Furthermore, prophylaxis with urea-containing cream (5-10%) should be applied several times a day.
This group receives a 30-minute nursing consultation on the standard treatment according to the guideline "Supportive Therapy" for hand-foot syndrome. The nursing consultation includes recommended basic measures for the prophylaxis of hand-foot syndrome such as the avoidance of mechanical stress and chemical irritants. In addition, treatment of pre-existing skin conditions is recommended. Furthermore, prophylaxis with urea-containing cream (5-10%) should be applied several times a day.
Robert-Bosch-Hospital
Stuttgart, Germany
Number of patients that can be recruited in a 9 months time period
The number of patients that can be recruited in a 9 months time period will be recorded in the study center
Time frame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
Proportion of potentially eligible patients that agree to participate in the study and thus to randomization
The proportion of potentially eligible patients that agree to participate in the study and thus to randomization will be recorded in the study center
Time frame: 7 days after last chemotherapy cycle (each cycle 3-4 weeks )
Proportion of randomized patients who leave the study early
The proportion of randomized patients who leave the study early will be recorded in the study center
Time frame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
Number of days in which the symptom diary was completed correctly
Symptoms will be collected daily in a symptom diary. The completeness of each patient diary will be assessed.
Time frame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
Number of days in which the intervention was carried out per protocol
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.
Time frame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
Prevention of the hand-foot syndrome
Prevention of the hand-foot syndrome (WHO-scale daily rating)
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Time frame: 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
Severity of the hand-foot syndrome (WHO-scale daily rating)
Time frame: From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks)
Pain in hands and feet
Pain in hands and feet (Numerical Rating Scale daily rating)
Time frame: 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
Sensory disturbances in the hands and feet (Numerical Rating Scale daily rating)
Time frame: 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
Impairment of daily life due to the changes in the hands and feet (Numerical Rating Scale daily rating)
Time frame: 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
The DLQI provides information about changes over the course of therapy. It is a useful tool to determine the success of ongoing treatment. It is the most commonly used instrument in randomized controlled trials in dermatology.
Time frame: 7 days after the first chemotherapy cycle (each cycle is 3-4 weeks)
Dermatology Life Quality Index (DLQI) questionnaire
The DLQI provides information about changes over the course of therapy. It is a useful tool to determine the success of ongoing treatment. It is the most commonly used instrument in randomized controlled trials in dermatology.
Time frame: 7 days after the third chemotherapy cycle (each cycle is 3-4 weeks)
Dermatology Life Quality Index (DLQI) questionnaire
The DLQI provides information about changes over the course of therapy. It is a useful tool to determine the success of ongoing treatment. It is the most commonly used instrument in randomized controlled trials in dermatology.
Time frame: 7 days after the last chemotherapy cycle "through study completion, an average of 1 year".(each cycle is 3-4 weeks)