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Completed

NCT Number: NCT05755646

Ice Plant Intensive Cream for the Prevention of Hand-Foot Syndrome in Breast Cancer: 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Robert-Bosch-Hospital

Stuttgart, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Secondary outcomes

  1. Prevention of the hand-foot syndrome

    Time frame: 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)

  2. Severity of the hand-foot syndrome

    Time frame: 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)

  3. Pain in hands and feet

    Time frame: 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)

  4. Sensory disturbances in the hands and feet

    Time frame: 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)

  5. Impairment of daily life due to the changes in the hands and feet

    Time frame: 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)

  6. Dermatology Life Quality Index (DLQI) questionnaire

    Time frame: 7 days after the first chemotherapy cycle (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.

  7. Dermatology Life Quality Index (DLQI) questionnaire

    Time frame: 7 days after the third chemotherapy cycle (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.

  8. Dermatology Life Quality Index (DLQI) questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Registry information

Official study 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

Acronym: WIn-HFS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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