Clinical trial NCT05755646: Ice Plant Intensive Cream for the Prevention of Hand-Foot Syndrome in Breast Cancer: Pilot Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand-Foot Syndrome
Breast Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
First posted: 2023-03-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients that can be recruited in a 9 months time period
timeFrame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
measure: Proportion of potentially eligible patients that agree to participate in the study and thus to randomization
timeFrame: 7 days after last chemotherapy cycle (each cycle 3-4 weeks )
measure: Proportion of randomized patients who leave the study early
timeFrame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
measure: Number of days in which the symptom diary was completed correctly
timeFrame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
measure: Number of days in which the intervention was carried out per protocol
timeFrame: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
Secondary outcomes:
measure: Prevention of the hand-foot syndrome
timeFrame: From the start of chemotherapy to 7 days after the last chemotherapy cycle (daily diary) (each cycle is 3-4 weeks)
measure: Severity of the hand-foot syndrome
timeFrame: From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks)
measure: Pain in hands and feet
timeFrame: From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks)
measure: Sensory disturbances in the hands and feet
timeFrame: From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks)
measure: Impairment of daily life due to the changes in the hands and feet
timeFrame: From the start of chemotherapy to 7 days after the last chemotherapy cycle (diary) (each cycle is 3-4 weeks)
measure: Dermatology Life Quality Index (DLQI) questionnaire
timeFrame: 7 days after the first chemotherapy cycle (each cycle is 3-4 weeks)
measure: Dermatology Life Quality Index (DLQI) questionnaire
timeFrame: 7 days after the third chemotherapy cycle (each cycle is 3-4 weeks)
measure: Dermatology Life Quality Index (DLQI) questionnaire
timeFrame: 7 days after the last chemotherapy cycle "through study completion, an average of 1 year".(each cycle is 3-4 weeks)
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital
Study officials:
References: