Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling
Official title: Multimodal Evaluation of Cryotherapy to Reduce Incidence of Chemotherapy-induced Peripheral Neurotoxicity in Breast Cancer Patients Treated With Paclitaxel Weekly
Run by Azienda Sanitaria dell'Alto Adige · NCT07780955 · Data updated 2026-11-12
This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | Women only |
| Enrollment | 144 (estimated) |
| Sponsor | Azienda Sanitaria dell'Alto Adige Academic / other |
| Drugs / interventions | Trastuzumab, Pertuzumab, Cyclophosphamide, Doxorubicin, chemotherapy |
| Locations | 4 sites (Bolzano, Bolzano and 3 other locations) |
| Status | Recruiting |
| Started | October 11, 2025 |
| Main results expected | July 2028 |
| Study ends | October 2028 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07780955 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (18–90) with breast cancer receiving weekly paclitaxel-based chemotherapy and ECOG 0–1 who consent to participate and do not have exclusion criteria related to neuropathy or vascular issues.
✕Probably not a fit
Patients with pre-existing neuropathy, Raynaud's syndrome, hand/feet metastases, peripheral arterial disease, or other factors that could interfere with data collection may not benefit or could be at risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Women with breast cancer receiving weekly paclitaxel are being assigned to receive continuous-flow cryotherapy at 15°C during each infusion or standard care. Participants will be followed for one year with neurological exams, nerve conduction studies, quality-of-life questionnaires, and blood tests to monitor nerve health and potential biomarkers of nerve damage. The goal is to see if cryotherapy can lower the incidence and severity of chemotherapy-induced peripheral neuropathy without introducing significant safety concerns. Data collected will include serial assessments during treatment and throughout follow-up to characterize potential long-term effects on nerve function and patient well-being.
Why it matters
Potential benefit: If successful, cryotherapy could reduce CIPN, helping patients stay on treatment and maintain daily functioning.
How similar studies have gone: Prior approaches using cooling to mitigate CIPN have shown potential signals, but results vary and this study adds a prospective, biomarker-inclusive evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Paclitaxel weekly (80 mg/m2) at least 12 cycles (in adjuvant, neo-adjuvant setting or metastatic setting following the present schemes: TH (Paclitaxel, Trastuzumab), AC-TH (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab), AC-THP (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab), AC-T (Doxorubicin, Cyclophosphamide, Paclitaxel) * Eastern Cooperative Oncology Group Performance Status (ECOG) \< 2 * Female sex * Age: 18-90 years * written informed consent Exclusion Criteria: * pre-existing motor/sensitive peripheral neuropathy * diabetes * Endocrinopathies * presence of brain, bone, soft tissue, or skin of hands or feet metastases * Raynaud's syndrome * Peripheral arterial disease * hand and foot syndrome * any other reason that may hamper the data collection as assessed by the examiner
Where it's running
-
Ospedale di Bressanone
Brixen, Bolzano, Italy Recruiting -
Ospedale di Brunico
Bruneck, Bolzano, Italy Recruiting -
Ospedale di Merano
Merano, Bolzano, Italy Recruiting -
Ospedale di Bolzano
Bolzano, Bolzano, Italy Not yet recruiting
Study contacts
- Study coordinator: Mattia Bergamo, MD
- Email: mattia.bergamo@sabes.it
- Phone: +390472812568
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Scrambler Therapy for chemotherapy-related nerve pain (CIPN).
Researchers will try Scrambler Therapy, a non-drug electrical treatment, to reduce pain and numbness in people with long-lasting chemotherapy-induced peripheral neuropathy.
-
VMD-3866 topical gel for chemotherapy-induced nerve pain
This trial will test whether a non-opioid topical gel called VMD-3866 can reduce pain in adults with chemotherapy-induced peripheral neuropathy.
-
Cryocompression to prevent taxane-induced nerve damage in the arms and legs.
This study tests whether cooling and pressure applied to the arms and legs during taxane chemotherapy can prevent or reduce numbness, pain, or weakness from peripheral neuropathy in adults with breast or gynecologic cancer.
-
Explicit Sensory Retraining for Chemo-Induced Peripheral Neuropathy
This study tests whether three sessions of explicit sensory retraining for the legs, compared with usual care, can help reduce symptoms and improve function in adults with CIPN after chemotherapy.
-
SIR2501 plus Paclitaxel for solid tumors
This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.
-
Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy
This study tests whether adding a structured exercise program to electroacupuncture helps cancer survivors with CIPN more than electroacupuncture alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.