An interventional study of Continuous Controlled Cooling of the Hands and Feet in Chemotherapy Induced Peripheral Neuropathy (CIPN), sponsored by Vastra Gotaland Region. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Prevention
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.
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.
12,844 studies on the registry are indexed under Breast Neoplasms; 2,939 are open to participants now.
This study's planned enrollment of 148 is above the median of 72 across 9,517 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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.
Device: Continuous Controlled Cooling of the Hands and Feet
Participants receive standard care without a cooling intervention for the prevention of chemotherapy-induced peripheral neuropathy.
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.
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.
Time frame: From enrollment to 6 months after completion of taxane-based chemotherapy
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.
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
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.
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
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
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
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
Incidence of adverse device effects related to hilotherapy, including cold intolerance, skin changes, and other adverse events associated with the study device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
Association Between Circulating Tau Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy
Tau 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 Tau concentration. Unit of measure fot tau: pg/mL Unit of Measure: Odds ratio per 1 SD increase in Tau concentration
Time frame: Tau 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.
Circulating Tau Levels During and After Taxane-Based Chemotherapy
Circulating Tau levels will be compared between the hilotherapy and standard care groups over time to evaluate whether hilotherapy influences Big-Tau levels during and after taxane-based chemotherapy. Unit of Measure: pg/mL
Time frame: 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.
Plan to share: No
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Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 2,281 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 12 months is below that.
Counting every sponsor, half of 2,354 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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