Ice Plant Intensive Cream for the Prevention of Hand-Foot Syndrome in Breast Cancer: Pilot Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hand-Foot Syndrome, Breast Cancer

Intervention / Treatment
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* Other: Ice Plant Intensive Cream plus Standard Care
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer patients Therapy with Doxorubicin and/or Docetaxel Karnofsky performance status scale > 80 Informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ice Plant Intensive Cream plus Standard Care<br>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. | Other: Ice Plant Intensive Cream plus Standard Care<br>* 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.<br>|
| Active Comparator: Standard Care<br>This group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome. | Other: Standard Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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. | 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. | 7 days after last chemotherapy cycle (each cycle is 3-4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of the hand-foot syndrome | Prevention of the hand-foot syndrome (WHO-scale daily rating) | 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) | 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) | 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) | 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) | 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. | 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. | 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. | 7 days after the last chemotherapy cycle through study completion, an average of 1 year.(each cycle is 3-4 weeks) |