Chemotherapy Induced Peripheral Neuropathy (CIPN)COOL-taxNCT07917026
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
A study of Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain types of chemotherapy and can cause numbness, tingling, pain, and other symptoms in the hands and feet. There is currently no established method for preventing CIPN. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2026to 1 Apr 2028
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Patients with breast cancer scheduled to receive taxane-based chemotherapy in the adjuvant or neoadjuvant setting
Who cannot join
- Presence of metastatic disease.
- Pre-existing peripheral neuropathy CTCAE grade ≥2.
- Prior treatment with neurotoxic chemotherapy, including taxanes, platinum compounds, vinca alkaloids, or other agents associated with chemotherapy-induced peripheral neuropathy.
- Known cold intolerance or hypersensitivity to cold exposure.
- Contraindications to the use of Hilotherm, including Raynaud's phenomenon or - Raynaud's disease, cryoglobulinemia, severe peripheral arterial disease, cold agglutinin disease, or other clinically significant arterial disorders.
- Insufficient understanding of the Swedish language to complete study procedures and questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 45
Malin Rydholm, MD, +46 31 342 10 00, malin.rydholm@vgregion.se
About this study
Official title: Continuous Controlled Cooling for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Randomized Controlled Trial
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain types of chemotherapy and can cause numbness, tingling, pain, and other symptoms in the hands and feet. There is currently no established method for preventing CIPN.
The purpose of this randomized controlled trial is to investigate whether continuous, controlled cooling of the hands and feet during chemotherapy can reduce the development and severity of CIPN. Participants will be randomly assigned to receive either cooling with the Hilotherm device during chemotherapy or standard care without cooling.
The study will compare peripheral neuropathy between the two groups and assess whether continuous cooling can help prevent chemotherapy-induced peripheral neuropathy.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and potentially long-lasting adverse effect of taxane-based chemotherapy. Currently, there is no established preventive treatment for CIPN. Previous studies of cooling interventions have shown promising results, but the available evidence remains limited.
The proposed mechanism of cooling is cold-induced vasoconstriction, which may reduce peripheral exposure to neurotoxic chemotherapy agents. Conventional cryotherapy using frozen gloves and socks has practical limitations, including fluctuating temperatures, frequent replacement, patient discomfort, and increased workload for healthcare personnel. Continuous cooling with hilotherapy provides stable temperature control and may therefore offer a more tolerable and feasible approach.
This study will evaluate whether hilotherapy can reduce chemotherapy-induced peripheral neuropathy in patients with non-metastatic breast cancer receiving taxane-based chemotherapy. The study will also provide information on the feasibility and acceptability of implementing hilotherapy in routine oncology care and explore circulating biomarkers in relation to the development of neuropathy.
- Being tested
- Continuous Controlled Cooling of the Hands and Feet
- Keywords
- CIPN, breast cancer, hilotherapy, cooling, taxanes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Controlled Cooling of the Hands and FeetDevice
Bilateral continuous controlled cooling of the hands and feet using the Hilotherm® device at a target temperature of 15°C. Cooling is initiated 30 minutes before the chemotherapy infusion, continued throughout the infusion, and maintained for 30 minutes after completion of the infusion. Cooling is administered at each taxane-based chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hilotherapy | Experimental | Participants receive bilateral hilotherapy of the hands and feet using the Hilotherm® device at a target temperature of 15°C. Cooling is initiated 30 minutes before the chemotherapy infusion, continued throughout the infusion, and maintained for 30 minutes after completion of chemotherapy. Receives: Device: Continuous Controlled Cooling of the Hands and Feet |
| Standard Care | No intervention | Participants receive standard care without a cooling intervention for the prevention of chemotherapy-induced peripheral neuropathy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Clinically meaningful chemotherapy-induced peripheral neuropathy (CIPN) is defined as a ≥10-point increase from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) sensory subscale score. The EORTC QLQ-CIPN20 is a patient-reported questionnaire assessing symptoms and functional impairment related to CIPN. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden.
Measured: From enrollment to 6 months after completion of taxane-based chemotherapy
Secondary outcomes (14)
Incidence of NCI-CTCAE Grade ≥2 Peripheral Neuropathy
Incidence of NCI-CTCAE grade ≥2 peripheral sensory neuropathy, peripheral motor neuropathy, and paresthesia. Neuropathy is assessed by healthcare professionals using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Measured: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable), and 6 months after completion of taxane treatment.
Change in EORTC QLQ-CIPN20 Motor and autonomic Subscale Score
Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item module (EORTC QLQ-CIPN20) motor and autonomic subscale scores.
Both subscale scores are transformed to a 0-100 scale (minimum 0, maximum 100). Higher scores indicate greater symptom burden and therefore a worse outcome. Change from baseline reflects the difference between the follow-up and baseline score; accordingly, an increase indicates worsening symptoms, while a decrease indicates improvement.
Measured: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable), and 6 months after completion of taxane treatment.
Incremental Cost per Avoided Case of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Cost-effectiveness will be evaluated as the incremental cost per avoided case of clinically meaningful chemotherapy-induced peripheral neuropathy (CIPN). Direct healthcare costs will include intervention costs, staff time, chemotherapy delivery, and healthcare utilization related to CIPN.
Unit of Measure: SEK per avoided case of clinically meaningful CIPN
Measured: Through 6 months after completion of chemotherapy
Cost-utility - Incremental Cost per Quality-Adjusted Life Year Gained
Cost-utility will be evaluated as the incremental cost per quality-adjusted life year (QALY) gained. Health utilities will be derived from the EQ-5D and used to estimate QALYs. Incremental costs and incremental QALYs will be compared between the hilotherapy and standard care groups to estimate the incremental cost per QALY gained. Unit of measure: SEK per QALY gained
Measured: From baseline through 6 months after completion of taxane-based chemotherapy.
Feasibility and Acceptability of Hilotherapy Implementation
Feasibility and acceptability of implementing hilotherapy in routine oncology care will be assessed through qualitative focus group interviews with nursing staff and management, including experiences and challenges related to implementation.
Measured: Prior to intervention start and immediately after completion of the intervention.
Patient Experience of Hilotherapy
Patient experiences of hilotherapy, including perceived benefits, challenges, tolerability, and acceptability, will be assessed through semi-structured individual interviews and analyzed using qualitative content analysis.
Measured: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Staff Time and Resource Use Associated With Hilotherapy
Difference in time and staff resources between the intervention and control groups. Healthcare personnel will prospectively record time spent on intervention-related activities and additional or unplanned work. Time will be recorded in minutes and aggregated to estimate staff time per patient.
Measured: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Change in Circulating Neurofilament Light Chain Levels
Circulating neurofilament light chain (NfL) levels will be compared between the hilotherapy and standard care groups over time to evaluate whether hilotherapy influences NfL levels during and after taxane-based chemotherapy. Unit of Measure:
pg/mL
Measured: NfL assessments: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable; each cycle is 3 weeks), and 6 months after completion of taxane treatment.
Association Between Circulating Neurofilament Light Chain Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy
Plasma neurofilament light chain (NfL) concentration will be evaluated as a predictor of subsequent clinically meaningful patient-reported chemotherapy-induced peripheral neuropathy (CIPN). Clinically meaningful CIPN will be defined as a ≥10-point increase from baseline in the EORTC QLQ-CIPN20 sensory subscale score. Scores range from 0 to 100, with higher scores indicating greater sensory neuropathy symptom burden. The association will be expressed as the odds ratio for developing clinically meaningful sensory CIPN per 1 standard deviation (SD) increase in NfL concentration.
Unit of Measure:
Odds ratio per 1 SD increase in NfL concentration
Measured: NfL and CIPN assessments: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable; each cycle is 3 weeks), and 6 months after completion of taxane treatment.
Incidence of Adverse Device Effects Related to Hilotherapy
Incidence of adverse device effects related to hilotherapy, including cold intolerance, skin changes, and other adverse events associated with the study device.
Measured: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Percentage of Participants With Taxane Dose Reduction
Percentage of participants in each treatment group who experience at least one taxane dose reduction during taxane-based chemotherapy.
Measured: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Impact of Hilotherapy on Chemotherapy Delivery
Comparison between the hilotherapy and standard care groups regarding chemotherapy delivery, including dose reductions, dose delays, and premature treatment discontinuation during taxane-based chemotherapy.
Measured: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Percentage of Participants With Taxane Dose Delay
Percentage of participants in each treatment group who experience at least one taxane dose delay during taxane-based chemotherapy.
Measured: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Percentage of Participants With Premature Discontinuation of Taxane Treatment
Percentage of participants in each treatment group who discontinue taxane treatment before completion of the planned treatment course.
Measured: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Apr 2028 (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 Neuropathy (CIPN)Studies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Per Karlsson, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917026
- Sponsor's protocol ID
- 2026-04974-01
- Acronym
- COOL-tax
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Controlled Cooling for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07917026
- Acronym / sponsor ID
- COOL-tax / 2026-04974-01
- Keywords
- CIPN, breast cancer, hilotherapy, cooling, taxanes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain types of chemotherapy and can cause numbness, tingling, pain, and other symptoms in the hands and feet. There is currently no established method for preventing CIPN.
The purpose of this randomized controlled trial is to investigate whether continuous, controlled cooling of the hands and feet during chemotherapy can reduce the development and severity of CIPN. Participants will be randomly assigned to receive either cooling with the Hilotherm device during chemotherapy or standard care without cooling.
The study will compare peripheral neuropathy between the two groups and assess whether continuous cooling can help prevent chemotherapy-induced peripheral neuropathy.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and potentially long-lasting adverse effect of taxane-based chemotherapy. Currently, there is no established preventive treatment for CIPN. Previous studies of cooling interventions have shown promising results, but the available evidence remains limited.
The proposed mechanism of cooling is cold-induced vasoconstriction, which may reduce peripheral exposure to neurotoxic chemotherapy agents. Conventional cryotherapy using frozen gloves and socks has practical limitations, including fluctuating temperatures, frequent replacement, patient discomfort, and increased workload for healthcare personnel. Continuous cooling with hilotherapy provides stable temperature control and may therefore offer a more tolerable and feasible approach.
This study will evaluate whether hilotherapy can reduce chemotherapy-induced peripheral neuropathy in patients with non-metastatic breast cancer receiving taxane-based chemotherapy. The study will also provide information on the feasibility and acceptability of implementing hilotherapy in routine oncology care and explore circulating biomarkers in relation to the development of neuropathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hilotherapy | Experimental | Device: Continuous Controlled Cooling of the Hands and FeetParticipants receive bilateral hilotherapy of the hands and feet using the Hilotherm® device at a target temperature of 15°C. Cooling is initiated 30 minutes before the chemotherapy infusion, continued throughout the infusion, and maintained for 30 minutes after completion of chemotherapy. |
| Standard Care | No intervention | –Participants receive standard care without a cooling intervention for the prevention of chemotherapy-induced peripheral neuropathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age
- Patients with breast cancer scheduled to receive taxane-based chemotherapy in the adjuvant or neoadjuvant setting
Key exclusion criteria (6 listed)
- Presence of metastatic disease.
- Pre-existing peripheral neuropathy CTCAE grade ≥2.
- Prior treatment with neurotoxic chemotherapy, including taxanes, platinum compounds, vinca alkaloids, or other agents associated with chemotherapy-induced peripheral neuropathy.
- Known cold intolerance or hypersensitivity to cold exposure.
- Contraindications to the use of Hilotherm, including Raynaud's phenomenon or - Raynaud's disease, cryoglobulinemia, severe peripheral arterial disease, cold agglutinin disease, or other clinically significant arterial disorders.
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 |
|---|---|---|
| Continuous Controlled Cooling of the Hands and FeetBilateral continuous controlled cooling of the hands and feet using the Hilotherm® device at a target temperature of 15°C. Cooling is initiated 30 minutes before the chemotherapy infusion, continued throughout the infusion, and maintained for 30 minutes after completion of the infusion. Cooling is administered at each taxane-based chemotherapy treatment. | Device | Hilotherapy |
Primary outcome
Incidence of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Time frame: From enrollment to 6 months after completion of taxane-based chemotherapy
Clinically meaningful chemotherapy-induced peripheral neuropathy (CIPN) is defined as a ≥10-point increase from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) sensory subscale score. The EORTC QLQ-CIPN20 is a patient-reported questionnaire assessing symptoms and functional impairment related to CIPN. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden.
14 secondary outcomes
Incidence of NCI-CTCAE Grade ≥2 Peripheral Neuropathy
Time frame: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable), and 6 months after completion of taxane treatment.
Change in EORTC QLQ-CIPN20 Motor and autonomic Subscale Score
Time frame: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable), and 6 months after completion of taxane treatment.
Incremental Cost per Avoided Case of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Time frame: Through 6 months after completion of chemotherapy
Cost-utility - Incremental Cost per Quality-Adjusted Life Year Gained
Time frame: From baseline through 6 months after completion of taxane-based chemotherapy.
Feasibility and Acceptability of Hilotherapy Implementation
Time frame: Prior to intervention start and immediately after completion of the intervention.
Patient Experience of Hilotherapy
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Staff Time and Resource Use Associated With Hilotherapy
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Change in Circulating Neurofilament Light Chain Levels
Time frame: NfL assessments: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable; each cycle is 3 weeks), and 6 months after completion of taxane treatment.
Association Between Circulating Neurofilament Light Chain Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy
Time frame: NfL and CIPN assessments: Baseline (before chemotherapy), at initiation of taxane treatment (Week 0), at Weeks 3, 6, and 9 (if applicable; each cycle is 3 weeks), and 6 months after completion of taxane treatment.
Incidence of Adverse Device Effects Related to Hilotherapy
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Percentage of Participants With Taxane Dose Reduction
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Impact of Hilotherapy on Chemotherapy Delivery
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Percentage of Participants With Taxane Dose Delay
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Percentage of Participants With Premature Discontinuation of Taxane Treatment
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 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 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Per Karlsson, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Vastra Gotaland Region at 1 site in Sweden.
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 2 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: opening soon, as of the sponsor's last update on 4 Nov 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 Sweden. 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 Malin Rydholm, MD (+46 31 342 10 00, malin.rydholm@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy (time frame: From enrollment to 6 months after completion of taxane-based 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 Nov 2026.