Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy (COOL-tax)
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Malin Rydholm, MD
- Numéro de téléphone: +46 31 342 10 00
- E-mail: malin.rydholm@vgregion.se
Lieux d'étude
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Västra Götaland County
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Gothenburg, Västra Götaland County, Suède, 413 45
- Sahlgrenska University Hospital
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Contact:
- Malin Rydholm, MD
- Numéro de téléphone: +46 31 342 10 00
- E-mail: malin.rydholm@vgregion.se
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ≥18 years of age
- Patients with breast cancer scheduled to receive taxane-based chemotherapy in the adjuvant or neoadjuvant setting
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Hilotherapy
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. |
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. |
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Aucune intervention: Standard Care
Participants receive standard care without a cooling intervention for the prevention of chemotherapy-induced peripheral neuropathy. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Délai: From enrollment to 6 months after completion of taxane-based chemotherapy
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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. |
From enrollment to 6 months after completion of taxane-based chemotherapy
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of NCI-CTCAE Grade ≥2 Peripheral Neuropathy
Délai: 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.
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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. |
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.
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Change in EORTC QLQ-CIPN20 Motor and autonomic Subscale Score
Délai: 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.
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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. |
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.
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Incremental Cost per Avoided Case of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Délai: Through 6 months after completion of chemotherapy
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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 |
Through 6 months after completion of chemotherapy
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Cost-utility - Incremental Cost per Quality-Adjusted Life Year Gained
Délai: From baseline through 6 months after completion of taxane-based chemotherapy.
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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 |
From baseline through 6 months after completion of taxane-based chemotherapy.
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Feasibility and Acceptability of Hilotherapy Implementation
Délai: Prior to intervention start and immediately after completion of the intervention.
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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. |
Prior to intervention start and immediately after completion of the intervention.
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Patient Experience of Hilotherapy
Délai: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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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. |
From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Staff Time and Resource Use Associated With Hilotherapy
Délai: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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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. |
From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Change in Circulating Neurofilament Light Chain Levels
Délai: 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.
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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 |
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.
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Association Between Circulating Neurofilament Light Chain Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy
Délai: 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.
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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 |
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.
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Incidence of Adverse Device Effects Related to Hilotherapy
Délai: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Incidence of adverse device effects related to hilotherapy, including cold intolerance, skin changes, and other adverse events associated with the study device. |
From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Percentage of Participants With Taxane Dose Reduction
Délai: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Percentage of participants in each treatment group who experience at least one taxane dose reduction during taxane-based chemotherapy. |
From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Impact of Hilotherapy on Chemotherapy Delivery
Délai: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Comparison between the hilotherapy and standard care groups regarding chemotherapy delivery, including dose reductions, dose delays, and premature treatment discontinuation during taxane-based chemotherapy. |
From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Percentage of Participants With Taxane Dose Delay
Délai: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Percentage of participants in each treatment group who experience at least one taxane dose delay during taxane-based chemotherapy. |
From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Percentage of Participants With Premature Discontinuation of Taxane Treatment
Délai: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Percentage of participants in each treatment group who discontinue taxane treatment before completion of the planned treatment course. |
From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Association Between Circulating Tau Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy
Délai: 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.
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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 |
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.
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Circulating Tau Levels During and After Taxane-Based Chemotherapy
Délai: 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.
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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 |
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.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Per Karlsson, MD, PhD, Sahlgrenska University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-04974-01
Plan pour les données individuelles des participants (IPD)
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