Chemotherapy-induced Peripheral NeuropathyNCT04632797
Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy
A study testing Hilotherm Chemo Care in people with Chemotherapy-induced Peripheral Neuropathy and Chemotherapeutic Toxicity, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity
- What is being tested?
- Hilotherm Chemo Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteAustria
- Study dates
- 3 Feb 2020to 3 Feb 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with breast cancer or other gynecological tumors
- planned neoadjuvant, adjuvant or palliative chemotherapy
- </= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line)
- at least three cycles of chemotherapy with taxanes
- written consent
- 18 years and older
Who cannot join
- PNP >/= 2
- neuralgia
- metastases in bones, metastases in soft tissue (located in skin, hands or feet)
- Raynaud syndrome
- peripheral arterial ischemia
- hand-feet syndrome
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
About this study
Official title: CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy
This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes.
Patients who are not eligible for either cryocompression or cryotherapy are included in a control group.
The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.
Read the detailed description
In this randomized, observer blinded, monocentric study 196 patients will be included in a four years period.
The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who are not eligible for either cryocompression or cryotherapy will be included in the control group.
Additionally every patient (excluding the control group) receives cryotherapy for the feet.
Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination (SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity
- Being tested
- Hilotherm Chemo Care
- Keywords
- Breast Cancer, Cervix Cancer, Endometrium Cancer, Ovarial Cancer, CIPN, Taxane
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hilotherm Chemo CareDevice
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
| Study group | Role | What they receive |
|---|---|---|
| Cryocompression | Active comparator | Patients in this group receive cryocompression for the hands. Receives: Device: Hilotherm Chemo Care |
| Cryotherapy | Active comparator | Patients in this group receive cryotherapy for the hands. Receives: Device: Hilotherm Chemo Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCV (nerve conduction velocity)
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Measured: 4 years
CTCAE 4.03
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Measured: 4 years
SWME (Semmes Weinstein monofilament examination)
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Measured: 4 years
tuning-fork-test
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Measured: 4 years
EORTC QoLCIPN20
Patient-reported outcomes (PRO)
Measured: 4 years
Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)
Patient-reported outcomes (PRO)
Measured: 4 years
Secondary outcomes (2)
National Cancer Institute Common Toxicity Criteria version 2
Changes of nails
Measured: 4 years
time frame until polyneuopathy occurs
time frame until polyneuopathy occurs whilst receiving Taxanes
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start3 Feb 2020
- Primary completion3 Feb 2022 (estimated)
- Study completion3 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Model description
- 1 to 1 randomization in either cryocompression or cryotherapy of the hands
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Brunner, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632797
- Sponsor's protocol ID
- 1224/2018
- Status last verified
- Feb 2020
- First submitted
- 21 Oct 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT04632797
- Acronym / sponsor ID
- 1224/2018
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity
- Keywords
- Breast Cancer, Cervix Cancer, Endometrium Cancer, Ovarial Cancer, CIPN, Taxane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 3 Feb 2022 (estimated)
- Study completion
- 3 Feb 2024 (estimated)
- First posted
- 17 Nov 2020 (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.
This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes.
Patients who are not eligible for either cryocompression or cryotherapy are included in a control group.
The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.
Detailed description
In this randomized, observer blinded, monocentric study 196 patients will be included in a four years period.
The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who are not eligible for either cryocompression or cryotherapy will be included in the control group.
Additionally every patient (excluding the control group) receives cryotherapy for the feet.
Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination (SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 to 1 randomization in either cryocompression or cryotherapy of the hands
| Arm | Type | Receives |
|---|---|---|
| Cryocompression | Active comparator | Device: Hilotherm Chemo CarePatients in this group receive cryocompression for the hands. |
| Cryotherapy | Active comparator | Device: Hilotherm Chemo CarePatients in this group receive cryotherapy for the hands. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with breast cancer or other gynecological tumors
- planned neoadjuvant, adjuvant or palliative chemotherapy
- </= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line)
- at least three cycles of chemotherapy with taxanes
- written consent
Key exclusion criteria (6 listed)
- PNP >/= 2
- neuralgia
- metastases in bones, metastases in soft tissue (located in skin, hands or feet)
- Raynaud syndrome
- peripheral arterial ischemia
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 Chemo CareApplication of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application. | Device | Cryocompression, Cryotherapy |
Primary outcome
NCV (nerve conduction velocity)
Time frame: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
CTCAE 4.03
Time frame: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
SWME (Semmes Weinstein monofilament examination)
Time frame: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
tuning-fork-test
Time frame: 4 years
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
EORTC QoLCIPN20
Time frame: 4 years
Patient-reported outcomes (PRO)
Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)
Time frame: 4 years
Patient-reported outcomes (PRO)
2 secondary outcomes
National Cancer Institute Common Toxicity Criteria version 2
Time frame: 4 years
time frame until polyneuopathy occurs
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Christine Brunner principal investigator
Medical University Innsbruck
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 Chemo Care in people with Chemotherapy-induced Peripheral Neuropathy and Chemotherapeutic Toxicity, run by Medical University Innsbruck at 1 site in Austria.
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 6 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: status not confirmed, as of the sponsor's last update on 17 Nov 2020. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Brunner (+4351250481194, c.brunner@tirol-kliniken.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCV (nerve conduction velocity) (time frame: 4 years). The study lists 6 primary outcomes in all. 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 17 Nov 2020.