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| Name | Class |
|---|---|
| Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice Plant Intensive Cream plus Standard Care | Experimental | 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. |
|
| Standard Care | Active Comparator | This group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ice Plant Intensive Cream plus Standard Care | Other | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert-Bosch-Hospital | Stuttgart | Germany |
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|
| Standard Care | Other | 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. |
|
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) |
| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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