Hilotherapy (hands-and-feet cooling) to reduce taxane-related peripheral neuropathy in breast cancer
Effect of Hilotherapy on Quality of Life and Comfort Level in the Management of Symptoms Related to Taxane-Associated Peripheral Neuropathy in Breast Cancer Patients
NA · Acibadem University · NCT07345221
This trial will try using cooling sleeves on the hands and feet during taxane chemotherapy to see if it reduces peripheral neuropathy symptoms and improves comfort for people with breast cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acibadem University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT07345221 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing hilotherapy (controlled cooling sleeves applied to hands and feet) versus usual care in patients with primary breast cancer receiving taxane chemotherapy. The device is applied 30 minutes before each chemotherapy infusion, kept at about 12°C for hands and 14°C for feet, monitored during infusion, and continued for 60 minutes after infusion. Participants complete symptom and quality-of-life measures (LANSS, EORTC QLQ-C30, QLQ-CIPN20, General Comfort Scale) and undergo physical exams at baseline and throughout treatment. The trial is conducted at two Acibadem hospitals in Istanbul and follows a standardized protocol for each chemotherapy course.
Who should consider this trial
Good fit: Ideal candidates are people with primary breast cancer starting or receiving taxane-containing chemotherapy who have no prior diagnosis of peripheral neuropathy and can attend treatment visits at the study hospitals.
Not a fit: Patients with preexisting peripheral neuropathy, diabetes, autoimmune disease, Raynaud's, active lesions on hands/feet, extremity amputation, bleeding/clotting disorders, distant metastasis, or other excluded conditions are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, hilotherapy could reduce the severity of taxane-induced peripheral neuropathy and improve patient comfort and quality of life during chemotherapy.
How similar studies have performed: Prior small studies of limb cooling or cryotherapy for chemotherapy-related neuropathy and local toxicities have shown promising but mixed results, so this approach is plausible but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having a primary breast cancer diagnosis * Having received chemotherapy containing taxane compounds due to breast cancer * Not having been previously diagnosed with peripheral neuropathy Exclusion Criteria: * Presence of distant metastasis * History of psychiatric disorder * Diagnosed diseases such as diabetes mellitus, autoimmune disease, megaloblastic anemia, cervical/spinal disc herniation, Raynaud's * Active lesions on hands or feet * Bleeding/clotting disorder * Extremity amputation * Any problem that prevents cognitive, emotional and verbal communication
Where this trial is running
Istanbul and 1 other locations
- Acibadem Altunizade Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- Acibadem Maslak Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Nermin Ocaktan, Assist. Prof.
- Email: nermin.ocaktan@acibadem.edu.tr
- Phone: +90 533 737 33 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheric Neuropathy, hilotherapy, peripheric neuropathy, symptom management, pain, comfort