Hand-Foot SyndromeWIn-HFSNCT05755646
Ice Plant Intensive Cream for the Prevention of Hand-Foot Syndrome in Breast Cancer: Pilot Randomized Controlled Trial
A study of Hand-Foot Syndrome and Breast Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hand-Foot Syndrome, Breast Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 10 Mar 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients
- Therapy with Doxorubicin and/or Docetaxel
- Karnofsky performance status scale > 80
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Ice Plant Intensive Cream plus Standard Care, Standard Care
- Medical subject headings
- Hand-Foot Syndrome, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice Plant Intensive Cream plus Standard CareOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 7 days after last chemotherapy cycle (each cycle is 3-4 weeks)
Secondary outcomes (8)
Prevention of the hand-foot syndrome
Prevention of the hand-foot syndrome (WHO-scale daily rating)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days after the last chemotherapy cycle "through study completion, an average of 1 year".(each cycle is 3-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start10 Mar 2023
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand-Foot SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755646
- Sponsor's protocol ID
- S00748-NIM
- Acronym
- WIn-HFS
- Status last verified
- Jan 2023
- First submitted
- 30 Jan 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Winkler M, Arnhold R, Anheyer D, Idler C, Loffler F, Sauer G, Loffler C, Cramer H. Feasibility and acceptability of ice plant intensive cream in preventing hand-foot syndrome in breast cancer patients undergoing Doxorubicin and/or Docetaxel therapy: a randomized controlled pilot study. Front Oncol. 2026 Aug 31;16:1758165. doi: 10.3389/fonc.2026.1758165. eCollection 2026.
PubMed 42741060
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05755646
- Acronym / sponsor ID
- WIn-HFS / S00748-NIM
- Conditions
- Hand-Foot Syndrome, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice Plant Intensive Cream plus Standard Care | Experimental | Other: Ice Plant Intensive Cream plus Standard CareThis 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. |
| Standard Care | Active comparator | Other: Standard CareThis group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer patients
- Therapy with Doxorubicin and/or Docetaxel
- Karnofsky performance status scale > 80
- Informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice Plant Intensive Cream plus Standard CareThis 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. | Other | Ice Plant Intensive Cream plus Standard Care |
| Standard CareThis 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. | Other | Standard Care |
Primary outcome
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
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
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
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.
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.
8 secondary outcomes
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)
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)
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)
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)
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)
Dermatology Life Quality Index (DLQI) questionnaire
Time frame: 7 days after the first chemotherapy cycle (each cycle is 3-4 weeks)
Dermatology Life Quality Index (DLQI) questionnaire
Time frame: 7 days after the third chemotherapy cycle (each cycle is 3-4 weeks)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 42741060Winkler M, Arnhold R, Anheyer D, Idler C, Loffler F, Sauer G, Loffler C, Cramer H. Feasibility and acceptability of ice plant intensive cream in preventing hand-foot syndrome in breast cancer patients undergoing Doxorubicin and/or Docetaxel therapy: a randomized controlled pilot study. Front Oncol. 2026 Aug 31;16:1758165. doi: 10.3389/fonc.2026.1758165. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hand-Foot Syndrome and Breast Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05755646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.