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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Malin Rydholm, MD
- Telefonszám: +46 31 342 10 00
- E-mail: malin.rydholm@vgregion.se
Tanulmányi helyek
-
-
Västra Götaland County
-
Gothenburg, Västra Götaland County, Svédország, 413 45
- Sahlgrenska University Hospital
-
Kapcsolatba lépni:
- Malin Rydholm, MD
- Telefonszám: +46 31 342 10 00
- E-mail: malin.rydholm@vgregion.se
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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. |
|
Nincs beavatkozás: Standard Care
Participants receive standard care without a cooling intervention for the prevention of chemotherapy-induced peripheral neuropathy. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Incidence of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Időkeret: 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. |
From enrollment to 6 months after completion of taxane-based chemotherapy
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Incidence of NCI-CTCAE Grade ≥2 Peripheral Neuropathy
Időkeret: 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.
|
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.
|
|
Change in EORTC QLQ-CIPN20 Motor and autonomic Subscale Score
Időkeret: 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 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.
|
|
Incremental Cost per Avoided Case of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy
Időkeret: Through 6 months after completion of chemotherapy
|
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
|
|
Cost-utility - Incremental Cost per Quality-Adjusted Life Year Gained
Időkeret: From baseline through 6 months after completion of taxane-based chemotherapy.
|
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.
|
|
Feasibility and Acceptability of Hilotherapy Implementation
Időkeret: Prior to intervention start and immediately after completion of the intervention.
|
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.
|
|
Patient Experience of Hilotherapy
Időkeret: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
|
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.
|
|
Staff Time and Resource Use Associated With Hilotherapy
Időkeret: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
|
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.
|
|
Change in Circulating Neurofilament Light Chain Levels
Időkeret: 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.
|
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.
|
|
Association Between Circulating Neurofilament Light Chain Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy
Időkeret: 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.
|
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.
|
|
Incidence of Adverse Device Effects Related to Hilotherapy
Időkeret: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
|
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.
|
|
Percentage of Participants With Taxane Dose Reduction
Időkeret: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
|
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.
|
|
Impact of Hilotherapy on Chemotherapy Delivery
Időkeret: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
|
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.
|
|
Percentage of Participants With Taxane Dose Delay
Időkeret: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
|
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.
|
|
Percentage of Participants With Premature Discontinuation of Taxane Treatment
Időkeret: From initiation of taxane treatment through completion of taxane treatment, approximately 12 weeks.
|
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.
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Association Between Circulating Tau Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy
Időkeret: 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.
|
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.
|
|
Circulating Tau Levels During and After Taxane-Based Chemotherapy
Időkeret: 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 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.
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Per Karlsson, MD, PhD, Sahlgrenska University Hospital
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2026-04974-01
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .