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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Hand-Foot Syndrome
• Intervention / Treatment: Other: Ice Plant Intensive Cream plus Standard Care; Other: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany
    • Robert-Bosch-Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): May 6, 2024
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Chemically-Induced Disorders; Skin Diseases; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Dermatitis; Drug Eruptions; Drug Hypersensitivity; Skin and Connective Tissue Diseases; Breast Neoplasms; Hand-Foot Syndrome; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: S00748-NIM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No