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

NCT05755646 | Completed

• 1 other identifier: S00748-NIM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand-Foot Syndrome; Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• 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)

• 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)

• 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)

Study Arms (2)

Ice Plant Intensive Cream plus Standard Care

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

This group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome.

Other: Standard Care

Interventions

Ice Plant Intensive Cream plus Standard Care OTHER

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.

Ice Plant Intensive Cream plus Standard Care

Standard Care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients
• Therapy with Doxorubicin and/or Docetaxel
• Karnofsky performance status scale \> 80
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): collaborator

Study Sites (1)

Robert-Bosch-Hospital

Stuttgart, Germany

Location

MeSH Terms

Conditions

Hand-Foot Syndrome; Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 6, 2023
• Study Start: March 10, 2023
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: May 6, 2026

Record last verified: 2023-01

Locations

DE (1)