Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
NCT07917026, Not applicable, Not yet recruiting, Vastra Gotaland Region
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy | ClinicalTrials.gov |
| NCT number | NCT07917026 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 148 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Vastra Gotaland Region | ClinicalTrials.gov |
| Conditions | Chemotherapy Induced Peripheral Neuropathy (CIPN) | ClinicalTrials.gov |
| Interventions | Continuous Controlled Cooling of the Hands and Feet | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy | 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. | ClinicalTrials.gov |
| Secondary | Incidence of NCI-CTCAE Grade ≥2 Peripheral Neuropathy | 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. | ClinicalTrials.gov |
| Secondary | Change in EORTC QLQ-CIPN20 Motor and autonomic Subscale Score | 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. | ClinicalTrials.gov |
| Secondary | Incremental Cost per Avoided Case of Clinically Meaningful Chemotherapy-Induced Peripheral Neuropathy | 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 | ClinicalTrials.gov |
| Secondary | Cost-utility - Incremental Cost per Quality-Adjusted Life Year Gained | 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 | ClinicalTrials.gov |
| Secondary | Feasibility and Acceptability of Hilotherapy Implementation | 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. | ClinicalTrials.gov |
| Secondary | Patient Experience of Hilotherapy | 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. | ClinicalTrials.gov |
| Secondary | Staff Time and Resource Use Associated With Hilotherapy | 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. | ClinicalTrials.gov |
| Secondary | Change in Circulating Neurofilament Light Chain Levels | 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 | ClinicalTrials.gov |
| Secondary | Association Between Circulating Neurofilament Light Chain Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy | 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 | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Device Effects Related to Hilotherapy | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Taxane Dose Reduction | 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. | ClinicalTrials.gov |
| Secondary | Impact of Hilotherapy on Chemotherapy Delivery | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Taxane Dose Delay | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Premature Discontinuation of Taxane Treatment | 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. | ClinicalTrials.gov |
| Other | Association Between Circulating Tau Levels and Subsequent Chemotherapy-Induced Peripheral Neuropathy | 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 | ClinicalTrials.gov |
| Other | Circulating Tau Levels During and After Taxane-Based Chemotherapy | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)