Equipment and SuppliesHiPPoNCT06627348
Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy
A study testing Hilotherm ChemoCare in people with Equipment and Supplies, run by University of Ulm at 1 site in Germany.
Trial summary
Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Equipment and Supplies
- What is being tested?
- Hilotherm ChemoCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 17 Apr 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Written consent for participation in this trail
- Age ≥18 years
- Female
- Breast or genital cancer of the woman
- Planned application of a Taxan-based chemotherapy regimen (Paclitaxel, Nab-Paclitaxel, Docetaxel) independent of the therapy line
- Taxan- and Platin-naivity
- Sufficient knowledge of the German language to assure an adequat survey of patient's history
Who cannot join
- pre-existing peripheral polyneuropathy
- chemotherapy with taxan- and/or carboplatin-based regimens in a preceding therapy
- Existence of one of the following diseases: Diabetes mellitus (of any type), neurological diseases that are involving peripheral nerve damage (e.g. Multiple Sclerosis, Amytrophic lateral sclerosis, Parkinson's disease), chronic pain syndrome, Cryoglobulinemia, cold hemagglutination, cold hives / cold contact hives, Raynaud's disease, significant peripheral artery disease,
- Lack of knowledge of German
- Males
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Ulm
Ulm, Baden-Wurttemberg, 89075
Angelina Fink, Dr. med., +4973150058688, angelina.fink@uniklinik-ulm.de
About this study
Official title: Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy - a Unicentric, Prospective-controlled, Randomized Clinical Trial for Comparison of Local Hilotherapy Vs. No Therapy to Prevent Peripheral Polyneuropathy During Taxan-based Chemotherapy Regimen
Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women.
Read the detailed description
In this trial, patients receiving Taxan-based chemotherapy regimen e.g. paclitaxel, nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer, breast cancer, endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not. The cooling will be provided by a machine called Hilotherm ChemoCare unit and will be administered constantly at a temperature of 15-17°C. Randomization will be 50:50.
if a patient is randomized in the non-interventional arm, no cooling is allowed during the application of the chemotherapy.
To assess the occurance and the extent of peripheral neuropathy, a neurological examination will take place before the start of chemotherapy, in the middle of the planned cycles of chemotherapy and after the completion of the regimen.
Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires.
- Conditions
- Equipment and Supplies
- Being tested
- Hilotherm ChemoCare
- Keywords
- Chemo-induced Peripheral Polyneuropathy, Taxan, Hilotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hilotherm ChemoCareDevice
Hilotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hilotherapy | Active comparator | Cooling of hands and feet during Taxan-based chemotherapy Receives: Device: Hilotherm ChemoCare |
| No Cooling | No intervention | No cooling of hands and feet during Taxan-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of peripheral polyneuropathy
The primary endpoint of this study is the comparison of the incidence of a peripheral polyneuropathy (clinical Total Neuropathy Score cTNS ≥ 11) in patients with gynecologic malignoma that are undergoing Taxan-based chemotherapy regimen with or without a preventive hilotherapy of hands and feet.
Measured: Up to one year after the end of chemotherapy.
Secondary outcomes (7)
Changes in the result of electrophysical examinations
Changes in the result of electrophysical examinations before and after chemotherapy.
Measured: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Adverse effects of hilotherapy
Adverse effects of hilotherapy documented as any adverse event.
Measured: Up to one year after the end of chemotherapy.
Tolerance of chemotherapy
Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy.
Measured: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Patient reported Quality of Life
Quality of Life of patients measured with the EORTC QLQ-C30 questionnaire
Measured: Up to one year after the end of chemotherapy.
Residual Symptoms of Chemotherapy-induced polyneuropathy
Comparison of the time of regression, cTNS score of persisting symptoms and amount of patients without residues after end of chemotherapy and follow-up between patients with and without preventive hilotherapy.
Measured: Up to one year after the end of chemotherapy.
Subjective extent of CIPN
Subjective extent of CIPN as measured with the EORTC QLQ-CIPN20 (quality of life questionnaire regarding chemotherapy-induced peripheral neuropathy with 20 questins) questionnaire.
The qustionnaire consits of 20 items on 3 scales. The minimum is 0, the maximum is 100 points. The higher the score, the worse the CIPN.
Measured: Up to one year after the end of chemotherapy.
Acceptance of hilotherapy
Acceptance of hilotherapy measured as the amount of patients that have to stop local cold application during a session (up to 5 minutes) or terminate earlier or stop the treament completely for the rest of chemotherapy.
Measured: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start17 Apr 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equipment and SuppliesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Hilotherm
- Responsible party
- Principal investigator, Prof. Wolfgang Janni, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627348
- Sponsor's protocol ID
- HIPPO
- Acronym
- HiPPo
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy - a Unicentric, Prospective-controlled, Randomized Clinical Trial for Comparison of Local Hilotherapy Vs. No Therapy to Prevent Peripheral Polyneuropathy During Taxan-based Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT06627348
- Acronym / sponsor ID
- HiPPo / HIPPO
- Conditions
- Equipment and Supplies
- Keywords
- Chemo-induced Peripheral Polyneuropathy, Taxan, Hilotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Hilotherm
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Oct 2024 (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.
Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women.
Detailed description
In this trial, patients receiving Taxan-based chemotherapy regimen e.g. paclitaxel, nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer, breast cancer, endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not. The cooling will be provided by a machine called Hilotherm ChemoCare unit and will be administered constantly at a temperature of 15-17°C. Randomization will be 50:50.
if a patient is randomized in the non-interventional arm, no cooling is allowed during the application of the chemotherapy.
To assess the occurance and the extent of peripheral neuropathy, a neurological examination will take place before the start of chemotherapy, in the middle of the planned cycles of chemotherapy and after the completion of the regimen.
Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hilotherapy | Active comparator | Device: Hilotherm ChemoCareCooling of hands and feet during Taxan-based chemotherapy |
| No Cooling | No intervention | –No cooling of hands and feet during Taxan-based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written consent for participation in this trail
- Age ≥18 years
- Female
- Breast or genital cancer of the woman
- Planned application of a Taxan-based chemotherapy regimen (Paclitaxel, Nab-Paclitaxel, Docetaxel) independent of the therapy line
Key exclusion criteria (5 listed)
- pre-existing peripheral polyneuropathy
- chemotherapy with taxan- and/or carboplatin-based regimens in a preceding therapy
- Existence of one of the following diseases: Diabetes mellitus (of any type), neurological diseases that are involving peripheral nerve damage (e.g. Multiple Sclerosis, Amytrophic lateral sclerosis, Parkinson's disease), chronic pain syndrome, Cryoglobulinemia, cold hemagglutination, cold hives / cold contact hives, Raynaud's disease, significant peripheral artery disease,
- Lack of knowledge of German
- Males
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 |
|---|---|---|
| Hilotherm ChemoCareHilotherapy | Device | Hilotherapy |
Primary outcome
incidence of peripheral polyneuropathy
Time frame: Up to one year after the end of chemotherapy.
The primary endpoint of this study is the comparison of the incidence of a peripheral polyneuropathy (clinical Total Neuropathy Score cTNS ≥ 11) in patients with gynecologic malignoma that are undergoing Taxan-based chemotherapy regimen with or without a preventive hilotherapy of hands and feet.
7 secondary outcomes
Changes in the result of electrophysical examinations
Time frame: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Adverse effects of hilotherapy
Time frame: Up to one year after the end of chemotherapy.
Tolerance of chemotherapy
Time frame: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Patient reported Quality of Life
Time frame: Up to one year after the end of chemotherapy.
Residual Symptoms of Chemotherapy-induced polyneuropathy
Time frame: Up to one year after the end of chemotherapy.
Subjective extent of CIPN
Time frame: Up to one year after the end of chemotherapy.
Acceptance of hilotherapy
Time frame: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hilotherm ChemoCare in people with Equipment and Supplies, run by University of Ulm 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelina FINK, Dr. med. (+4973150058688, angelina.fink@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of peripheral polyneuropathy (time frame: Up to one year after the end of chemotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2024.