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

Breast Cancer Clinical Trial

— WIn-HFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05755646
• Other study ID #: S00748-NIM
• Status: Completed
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: May 2, 2024

Study information

• Verified date: January 2023
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hand-Foot Syndrome
• Syndrome

Intervention

Other:
• Ice 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.
• Standard 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.

Locations

Country	Name	City	State
Germany	Robert-Bosch-Hospital	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Robert Bosch Gesellschaft für Medizinische Forschung mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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 )
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)