MedTrace Logo

Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients

NCT06955702 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-22

No results posted yet for this study

Summary

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

  • Breast Neoplasms
  • Alopecia
  • Madarosis
  • Eyebrow Diseases
  • Eyelash Diseases
  • Anthracyclines
  • Taxoids
  • Side Effects

Interventions

DEVICE

cryotherapy for chemotherapy-induced madarosis

Application of temperature-controlled cold devices (-4°C to -7°C) to the supraorbital area (up to 3 cm above the eyelid margin), administered 15 minutes before chemotherapy infusion and maintained for 20 minutes post-infusion.

Sponsors & Collaborators

  • University of Salamanca

    lead OTHER

Principal Investigators

  • Marta González Fernández-Conde · Universidad Salamanca

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2025-07-31
Completion
2026-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955702 on ClinicalTrials.gov