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NCT07917026
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 148
Sponsor: Vastra Gotaland Region
Location: Sahlgrenska University Hospital Gothenburg Västra Götaland County
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.
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07917026). StuddyBuddy aggregates publicly available trial information.