La crioterapia per le onicopatie indotte da paclitaxel. CRIOP

Cryotherapy for onicopatie induced by paclitaxel. CRIOP - CRIOP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002748-16-IT

Enrollment

Registered

2021-01-25

Start date

2015-10-19

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: PACLITAXEL ACTAVIS - 6 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 50 ML Product Name: PACLITAXEL Product Code: L01CD01 Pharmaceutical Form: Solution for injecti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with breast cancer and undergoing adjuvant therapy with weekly paclitaxel (80 to 100 mg / m) for at least 12 weeks; 2) Collaboration and written informed consent to treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31

Exclusion criteria

Exclusion criteria: 1) Previous nail diseases; 2) Syndrome Raynoud; 3) Prior treatment with taxanes; 4) no treatment compliance or lack of cooperation

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the impact of cryotherapy in reducing the incidence of onicopatie of moderate / severe intensity in addition to the 12;Secondary Objective: 1) evaluate the "time to the appearance" of each of onicopatie degree calculated in number of days from the start of therapy; 2) assess the tolerance and patient compliance through the intervention of cryotherapy satisfaction scale to 2 items (satisfied, not satisfied). ;Primary end point(s):	—

Measure

Time frame

Main Objective: Assess the impact of cryotherapy in reducing the incidence of onicopatie of moderate / severe intensity in addition to the 12;Secondary Objective: 1) evaluate the "time to the appearance" of each of onicopatie degree calculated in number of days from the start of therapy; 2) assess the tolerance and patient compliance through the intervention of cryotherapy satisfaction scale to 2 items (satisfied, not satisfied). ;Primary end point(s):

—

Countries

Italy

Contacts

Public ContactUfficio Studi Clinici

Centro Riferimento Oncologico

gtabaro@cro.it0434659066

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026