Chemotherapy-induced Peripheral NeuropathyPOLARNCT06541769
CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression
A study testing Limb hypothermia and Limb compression in people with Chemotherapy-induced Peripheral Neuropathy and Onychodystrophy, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The POLAR study is a monocentric, prospective, randomized, 2-arm study designed to evaluate the effectiveness of compression or hypothermia in preventing higher-grade chemotherapy-induced peripheral neuropathy (CIPN) (Grade > 1 according to EORTC) in patients undergoing (neo-)adjuvant chemotherapy with weekly… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Onychodystrophy
- What is being tested?
- Limb hypothermia and Limb compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2019to 15 Jul 2022
- 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
- all female patients with signed informed consent who are starting with (neo-) adjuvant chemotherapy according to the following protocols:
- 4 x Epirubicin/Cyclophosphamid (EC) q3w, followed by 12 x Paclitaxel weekly or 12x Nab-Paclitaxel (+/- Trastuzumab)
- Paclitaxel or Nab-Paclitaxel weekly without anthracyclines
- Paclitaxel or Nab-Paclitaxel weekly in combination with Carboplatin
Who cannot join
- patients without informed consent
- ECOG-Status > 1
- age under 18 years
- previous chemotherapy
- therapy with SSNRI, SSRI, or tricyclic antidepressants especially duloxetine, gabapentine, pregabaline and amitryptiline.
- known polyneuropathy (e.g. alcoholic PNP, nephrogenic PNP, diabetic PNP etc.)
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- Patients having diseases connected to PNP:
- Sjögren-syndrome, sarkoidosis, amyloidneuropathy, Morbus Fabry, HSAN (Hereditary Sensoric and Autonome Neuropathy)
- Guillain-Barré-syndrome, acute intermittent porphyria, critical-illness-PNP
- Vaskulitides, HNPP, diabetic amyotrophy, multifokal motoric neuropathy, Lewis-Sumner-syndrome, borreliosis-neuropathy, Zoster-neuritis, neuralgic shoulder amyotrophy
- Myelopathy, compression of the myelon, syringomyelia, meningomyelitis, Restless-Legs-syndrome
- Sulcus-Ulnaris-syndrome, Loge-de-Guyon-syndrome, Medianus-compression-syndrome, multiple sklerosis, AML, Lupus erythematodes, sklerodermia/systemic sclerosis, Ehlers-Danlos-syndrome, CREST-syndrome, Raynaud-syndrome, cold aglutinin disease, hämatologic neoplasms, diabetes mellitus, chronic alcohol abuse, hepatitis C, known severe kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression in Patients Undergoing (Neo-) Adjuvant Chemotherapy for Primary Breast Cancer
The POLAR study is a monocentric, prospective, randomized, 2-arm study designed to evaluate the effectiveness of compression or hypothermia in preventing higher-grade chemotherapy-induced peripheral neuropathy (CIPN) (Grade > 1 according to EORTC) in patients undergoing (neo-)adjuvant chemotherapy with weekly Paclitaxel or Nab-Paclitaxel. In this study, the dominant hand of participants will be either cooled or compressed, while the contralateral hand will serve as a control. The treatment groups will be randomized.
The primary aim of the study is to compare the effectiveness of limb hypothermia versus compression in preventing CIPN. Additionally, the investigators will assess the quality of life and therapy acceptance among the participants in both study arms. Data from the two groups will be collected and compared to determine the most effective intervention for preventing CIPN and to understand the overall impact on patients' well-being and treatment adherence.
Read the detailed description
This is a prospective, randomized, two-arm study with the aim of assessing the effectiveness of compression or cooling in preventing higher-grade CIPN (>Grade 2 according to EORTC) during weekly paclitaxel or nab-paclitaxel based (neo-)adjuvant chemotherapy. For this purpose, the dominant hand is either cooled or compressed, depending on the study arm, and the contralateral hand is only observed. The allocation to compression or cooling is done through randomization. In a second step, the effectiveness of cooling should be compared with compression. For this purpose, the data collected from the two study arms will be compared. Furthermore, patient satisfaction and quality of life during therapy will be examined. The primary study endpoint is the difference in moderate and severe polyneuropathy (CTCAE grade ≥ 2) compared between the control hand and the intervention hand within the study arms (extremity with cooling vs. control extremity or extremity with compression vs. control extremity). CIPN is evaluated via CTCAE criteria 4.0 and by the Total Neuropathy Score (TNS; clinical version). In addition, sensorimotor symptoms are documented using EORTC QLQ-CIPN20 questionnaires (see also 3.3).
In a second, hierarchical test, the rate of moderate and severe polyneuropathies is compared between the two intervention arms (cooling vs. compression). The rate of onychodystrophies and onycholysis in both intervention arms (compression and cooling) is documented using CTAE criteria and compared between the intervention arm and the control arm as well as between both patient groups.
In addition, patient satisfaction and acceptance of the intervention are examined. EORTC QLQ-C30 questionnaires are used to document quality of life. Any toxicities during therapy are documented according to the CTCAE criteria 4.0.
- Being tested
- Limb hypothermia, Limb compression
- Keywords
- Breast cancer, CIPN, Peripheral neuropathy, hypothermia
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb hypothermiaDevice
Limb hypothermia with special gel-gloves
Limb compressionDevice
compression with sterile one way Latex gloves. Size measured for every Patient individually
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Experimental | limb Hypothermia with special hypothermia-gel-gloves of the dominant hand starting 30min before chemotherapy application and ending 30min after. The glove will be changed every 30min to provide constant cooling Receives: Device: Limb hypothermia |
| Compression | Experimental | compression of the dominant hand provided by one-way latex-gloves. The necessary size will be determined after measurement for every Patient individually Receives: Device: Limb compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CIPN grade >1 on the interventional hand compared to the non-interventional hand
Comparing rates of CIPN>grade 1 on the interventional and non-interventional hand by evaluation CTCAE criteria, EORTC QLQ-CIPN-20, the clinical version of the total neuropathy score (TNSc), Magnetic resonance neurography (MRI; n=21) and nerve conduction studies (n=4)
Measured: 1 year (during taxane therapy and follow up)
Secondary outcomes (3)
Incidence of onycholysis/onychodystrophy grade >1 on the interventional hand compared to the non-interventional hand
Comparing rates of onycholysis/onychodystrophy>grade 1 on the interventional and non-interventional hand
Measured: 1 year (during taxane therapy and follow up)
Magnetic resonance neurography (MRI) as a possible marker of CIPN
To evaluate the role of MRI as a possible marker for CIPN, MRI will be performed in a subset of patient (N=21)
Measured: 3 month (before and after taxane therapy)
Influence of CIPN on the quality of life
Standardized clinical questionnaires (EORTC QLQ30, QLQ-CIPN-20) are used to determine the quality of life.
Measured: 1 year (during taxane therapy and follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start15 Oct 2019
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
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 Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Michel, University Hospital Heidelberg
- Investigators
- Laura Michel, M.D., Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541769
- Sponsor's protocol ID
- NCT/HD_GYNONC:POLAR
- Acronym
- POLAR
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Michel LL, Schwarz D, Romar P, Feisst M, Hamberger D, Priester A, Kurre E, Klein E, Muller J, Schinkothe T, Weiler M, Smetanay K, Fremd C, Heublein S, Thewes V, Breckwoldt MO, Jager D, Bendszus M, Marme F, Schneeweiss A. Efficacy of Hand Cooling and Compression in Preventing Taxane-Induced Neuropathy: The POLAR Randomized Clinical Trial. JAMA Oncol. 2025 Apr 1;11(4):408-415. doi: 10.1001/jamaoncol.2025.0001.
PubMed 40048176
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression in Patients Undergoing (Neo-) Adjuvant Chemotherapy for Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT06541769
- Acronym / sponsor ID
- POLAR / NCT/HD_GYNONC:POLAR
- Keywords
- Breast cancer, CIPN, Peripheral neuropathy, hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 7 Aug 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.
The POLAR study is a monocentric, prospective, randomized, 2-arm study designed to evaluate the effectiveness of compression or hypothermia in preventing higher-grade chemotherapy-induced peripheral neuropathy (CIPN) (Grade > 1 according to EORTC) in patients undergoing (neo-)adjuvant chemotherapy with weekly Paclitaxel or Nab-Paclitaxel. In this study, the dominant hand of participants will be either cooled or compressed, while the contralateral hand will serve as a control. The treatment groups will be randomized.
The primary aim of the study is to compare the effectiveness of limb hypothermia versus compression in preventing CIPN. Additionally, the investigators will assess the quality of life and therapy acceptance among the participants in both study arms. Data from the two groups will be collected and compared to determine the most effective intervention for preventing CIPN and to understand the overall impact on patients' well-being and treatment adherence.
Detailed description
This is a prospective, randomized, two-arm study with the aim of assessing the effectiveness of compression or cooling in preventing higher-grade CIPN (>Grade 2 according to EORTC) during weekly paclitaxel or nab-paclitaxel based (neo-)adjuvant chemotherapy. For this purpose, the dominant hand is either cooled or compressed, depending on the study arm, and the contralateral hand is only observed. The allocation to compression or cooling is done through randomization. In a second step, the effectiveness of cooling should be compared with compression. For this purpose, the data collected from the two study arms will be compared. Furthermore, patient satisfaction and quality of life during therapy will be examined. The primary study endpoint is the difference in moderate and severe polyneuropathy (CTCAE grade ≥ 2) compared between the control hand and the intervention hand within the study arms (extremity with cooling vs. control extremity or extremity with compression vs. control extremity). CIPN is evaluated via CTCAE criteria 4.0 and by the Total Neuropathy Score (TNS; clinical version). In addition, sensorimotor symptoms are documented using EORTC QLQ-CIPN20 questionnaires (see also 3.3).
In a second, hierarchical test, the rate of moderate and severe polyneuropathies is compared between the two intervention arms (cooling vs. compression). The rate of onychodystrophies and onycholysis in both intervention arms (compression and cooling) is documented using CTAE criteria and compared between the intervention arm and the control arm as well as between both patient groups.
In addition, patient satisfaction and acceptance of the intervention are examined. EORTC QLQ-C30 questionnaires are used to document quality of life. Any toxicities during therapy are documented according to the CTCAE criteria 4.0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | Experimental | Device: Limb hypothermialimb Hypothermia with special hypothermia-gel-gloves of the dominant hand starting 30min before chemotherapy application and ending 30min after. The glove will be changed every 30min to provide constant cooling |
| Compression | Experimental | Device: Limb compressioncompression of the dominant hand provided by one-way latex-gloves. The necessary size will be determined after measurement for every Patient individually |
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)
- all female patients with signed informed consent who are starting with (neo-) adjuvant chemotherapy according to the following protocols:
- 4 x Epirubicin/Cyclophosphamid (EC) q3w, followed by 12 x Paclitaxel weekly or 12x Nab-Paclitaxel (+/- Trastuzumab)
- Paclitaxel or Nab-Paclitaxel weekly without anthracyclines
- Paclitaxel or Nab-Paclitaxel weekly in combination with Carboplatin
Key exclusion criteria (12 listed)
- patients without informed consent
- ECOG-Status > 1
- age under 18 years
- previous chemotherapy
- therapy with SSNRI, SSRI, or tricyclic antidepressants especially duloxetine, gabapentine, pregabaline and amitryptiline.
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 |
|---|---|---|
| Limb hypothermiaLimb hypothermia with special gel-gloves | Device | Hypothermia |
| Limb compressioncompression with sterile one way Latex gloves. Size measured for every Patient individually | Device | Compression |
Primary outcome
Incidence of CIPN grade >1 on the interventional hand compared to the non-interventional hand
Time frame: 1 year (during taxane therapy and follow up)
Comparing rates of CIPN>grade 1 on the interventional and non-interventional hand by evaluation CTCAE criteria, EORTC QLQ-CIPN-20, the clinical version of the total neuropathy score (TNSc), Magnetic resonance neurography (MRI; n=21) and nerve conduction studies (n=4)
3 secondary outcomes
Incidence of onycholysis/onychodystrophy grade >1 on the interventional hand compared to the non-interventional hand
Time frame: 1 year (during taxane therapy and follow up)
Magnetic resonance neurography (MRI) as a possible marker of CIPN
Time frame: 3 month (before and after taxane therapy)
Influence of CIPN on the quality of life
Time frame: 1 year (during taxane therapy and follow up)
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 7 Aug 2024.
- Derived from this study: PubMed 40048176Michel LL, Schwarz D, Romar P, Feisst M, Hamberger D, Priester A, Kurre E, Klein E, Muller J, Schinkothe T, Weiler M, Smetanay K, Fremd C, Heublein S, Thewes V, Breckwoldt MO, Jager D, Bendszus M, Marme F, Schneeweiss A. Efficacy of Hand Cooling and Compression in Preventing Taxane-Induced Neuropathy: The POLAR Randomized Clinical Trial. JAMA Oncol. 2025 Apr 1;11(4):408-415. doi: 10.1001/jamaoncol.2025.0001.
- 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.
Laura Michel, M.D. study director
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limb hypothermia and Limb compression in people with Chemotherapy-induced Peripheral Neuropathy and Onychodystrophy, run by University Hospital Heidelberg 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 12 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 7 Aug 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?
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?
Incidence of CIPN grade >1 on the interventional hand compared to the non-interventional hand (time frame: 1 year (during taxane therapy and follow up)). 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 NCT06541769, 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 7 Aug 2024.