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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hand-Foot Syndrome
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Number of days in which the intervention was carried out per protocol
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of days in which the intervention was carried out per protocol
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))