Actively Recruiting
Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients
Led by University of Salamanca · Updated on 2025-05-22
120
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chemotherapy-induced alopecia (CIA) significantly compromises body image in breast cancer patients, particularly when involving eyebrow and eyelash loss (madarosis). While scalp cooling devices are routinely employed to prevent scalp alopecia, no standardized interventions exist for madarosis prevention. This quasi-experimental study assesses the efficacy of targeted eyebrow cryotherapy in reducing anthracycline- and taxane-induced madarosis. The trial will enroll patients from two tertiary hospitals in Salamanca (intervention arm: cryotherapy) and a control cohort from Santander. Cryotherapy will be administered (-4°C to -7°C) 15 minutes pre-chemotherapy infusion and maintained for 20 minutes post-infusion. Primary outcomes include hair retention quantified through photogrammetric analysis (TIDOP Research Group) at four timepoints: baseline, mid-treatment, chemotherapy completion, and 1-month follow-up. Secondary endpoints evaluate quality of life (QLQ-C30 validated scales) and cryotherapy-related adverse events (CTCAE v5.0 criteria). This investigation aims to establish the first evidence-based protocol for madarosis prevention and develop a novel alopecia classification scale, addressing a critical gap in supportive oncology care
CONDITIONS
Official Title
Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 618 years
- Newly diagnosed breast cancer of any stage
- Scheduled for anthracycline- and/or taxane-based chemotherapy as first-line systemic treatment
- No prior antineoplastic treatment
- Willing and able to provide written informed consent
You will not qualify if you...
- History of prior hormone therapy, chemotherapy, or immunotherapy for recurrent disease
- Presence of alopecia before starting cancer treatment
- History of cerebral radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39011
Actively Recruiting
2
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
Research Team
M
Marta González Fernández-Conde, PhD Nursing
CONTACT
A
Aline Rodrigues Françoso, PhD Nursing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here