a crioterapia per le onicopatie indotte da paclitaxel. CRIOP
Phase 1
- Conditions
- breast cancerMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002748-16-IT
- Lead Sponsor
- CENTRO DI RIFERIMENTO ONCOLOGICO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 62
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
1) Previous nail diseases;
2) Syndrome Raynoud;
3) Prior treatment with taxanes;
4) no treatment compliance or lack of cooperation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br> 2) assess the tolerance and patient compliance through the intervention of cryotherapy satisfaction scale to 2 items (satisfied, not satisfied).<br>;Primary end point(s):
- Secondary Outcome Measures
Name Time Method