Breast Cancer, Hand-Foot Syndrome
Conditions
Brief summary
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.
Interventions
OTHERIce Plant Intensive Cream plus Standard Care
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.
OTHERStandard Care
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.
Sponsors
University Hospital Tuebingen
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients that can be recruited in a 9 months time period | 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 | 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 | 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 | 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. |
| Number of days in which the intervention was carried out per protocol | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Prevention of the hand-foot syndrome (WHO-scale daily rating) |
| 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) | Severity of the hand-foot syndrome (WHO-scale daily rating) |
| 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) | Pain in hands and feet (Numerical Rating Scale daily rating) |
| 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) | Sensory disturbances in the hands and feet (Numerical Rating Scale daily rating) |
| 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) | Impairment of daily life due to the changes in the hands and feet (Numerical Rating Scale daily rating) |
| Dermatology Life Quality Index (DLQI) questionnaire | 7 days after the first chemotherapy cycle (each cycle is 3-4 weeks) | 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. |
Countries
Germany
Outcome results
None listed