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

Not Applicable

Completed

• Conditions: Hand-Foot Syndrome; Breast Cancer
• Interventions: Other: Standard Care; Other: Ice Plant Intensive Cream plus Standard Care

• Registration Number: NCT05755646
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-06
• Study Start: 2023-03-10
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	This group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome.
Ice Plant Intensive Cream plus Standard Care	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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)
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)
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 last chemotherapy cycle "through study completion, an average of 1 year".(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.

Trial Locations

Locations (1)

Robert-Bosch-Hospital; 🇩🇪 Stuttgart, Germany