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

NCT06955702 | Recruiting

• 1 other identifier: PC_TCUE23-24_033
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Chemotherapy-induced alopecia; Madarosis; Eyebrow preservation; Taxane-induced alopecia; Anthracycline-induced alopecia; Cryotherapy; Supportive care in oncology; Quality of life; Scalp cooling; Patient-reported outcomes

Outcome Measures

Primary Outcomes (1)

• Eyebrow hair preservation rate

  Proportion of patients with ≤50% eyebrow hair loss (Grade 0-2 on CTCAE v5.0 adapted scale) at end of treatment, assessed via AI-based photogrammetry (TIDOP Group)

  From baseline to 1 month post-chemotherapy completion

Secondary Outcomes (6)

• Eyelash hair preservation rate

  From baseline to 1 month post-chemotherapy completion

• Control group madarosis incidence

  From baseline to 1 month post-chemotherapy completion

• Change in Body Image Score Measured by EORTC QLQ-BR23

  From baseline to 1 month post-chemotherapy completion

• Change in Eyelash Satisfaction measured by Eyelash Satisfaction Questionnaire (ESQ)

  From baseline to 1 month post-chemotherapy completion

• Cryotherapy-related adverse events

  From baseline through chemotherapy completion (approximately 20 to 24 weeks)

Study Arms (2)

Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes)

EXPERIMENTAL

Cryotherapy is administered via thermally regulated cold eye masks (-10°C ± 2°C) positioned over the supraorbital region, with application commencing 15 minutes pre-chemotherapy and continuing through the infusion period plus 20 minutes post-administration. Chemotherapy includes anthracyclines (doxorubicin/epirubicin) and/or taxanes (paclitaxel/docetaxel) per standard protocols.

Device: cryotherapy for chemotherapy-induced madarosis

Standard chemotherapy (no cryotherapy)

NO INTERVENTION

Patients receive anthracycline/taxane-based chemotherapy per institutional protocols without application of cold eye masks or any cryotherapy intervention. All other supportive care measures match the experimental group.

Interventions

cryotherapy for chemotherapy-induced madarosis DEVICE

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.

Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer is predominant in women (\>99% of cases).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged ≥18 years
• Newly diagnosed breast cancer (any stage)
• Scheduled to receive anthracycline- and/or taxane-based chemotherapy as first-line systemic treatment
• No prior history of antineoplastic treatment
• Willing and able to provide written informed consent

You may not qualify if:

• Patients with recurrent disease who have received prior hormone therapy, chemotherapy, and/or immunotherapy
• Presence of alopecia prior to the initiation of cancer treatment
• History of cerebral radiotherapy

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (2)

Hospital Marqués de Valdecilla

Santander, Cantabria, 39011, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Alopecia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marta González Fernández-Conde

  Universidad Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta González Fernández-Conde, PhD Nursing

CONTACT

661544179; martagfc@usal.es

Aline Rodrigues Françoso, PhD Nursing

CONTACT

645182581; arodrigues@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Due to the visible nature of cryotherapy, blinding of participants, providers, or assessors was not feasible. Photogrammetric analysis was automated (AI-based) to minimize bias in outcome measurement.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Nursing Professor Ávila School of Nursing (affiliated to University of Salamanca)

Model Details: Quasi-experimental parallel design comparing cryotherapy vs. standard care in two separate patient groups.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 2, 2025
• Study Start: November 15, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-04

Locations

ES (2)