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Hair Growth and Disorders / Chemotherapy-related Skin Toxicity · Journal article
PLOS One · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol for a phase III randomized controlled trial comparing automated scalp cooling (PAXMAN® PSCS 2) to standard cold-cap therapy for prevention of chemotherapy-induced alopecia in breast cancer patients. No efficacy or safety data are available; the study is planned but results are not yet reported.
Prospective, multicenter, open-label, randomized controlled trial, phase III. Female adult patients with histologically confirmed, non-metastatic localized breast cancer eligible for neoadjuvant or adjuvant anthracycline-taxane chemotherapy.. Intervention: Automated scalp cooling system (PAXMAN® PSCS 2). Compared with: Standard non-automated cold-cap therapy. n = 196. Three French cancer centers.
This is a protocol for a phase III randomized controlled trial comparing automated scalp cooling (PAXMAN® PSCS 2) to standard cold-cap therapy for prevention of chemotherapy-induced alopecia in breast cancer patients. No efficacy or safety data are available; the study is planned but results are not yet reported.
This is a protocol; no efficacy or safety results are reported.
Once results are available, this trial will be the first direct head-to-head comparison of automated scalp cooling versus standard cold-cap therapy and will inform clinical practice regarding efficacy, patient experience, and cost-effectiveness for CIA prevention.
This is a protocol paper describing a planned phase III RCT; no results are reported, only study design and endpoints.
As stated by the source record.
Quoted from the source exactly as published.
Once results are available, this trial will be the first direct head-to-head comparison of automated scalp cooling versus standard cold-cap therapy and will inform clinical practice regarding efficacy, patient experience, and cost-effectiveness for CIA prevention.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Background Chemotherapy-induced alopecia (CIA) remains one of the most distressing adverse effects for patients with localized breast cancer receiving anthracycline and taxane-based chemotherapy regimens. Although automated scalp cooling systems and standard non-automated cold-cap devices have demonstrated efficacy in reducing CIA, controlled trials with direct randomization comparing these two modalities of scalp cooling are lacking. This study aims to compare clinical efficacy, patient-reported outcomes, and medico-economic impact of a scalp cooling system (PAXMAN® PSCS 2) versus standard cold-cap therapy in preventing CIA. Methods/Design ICELAND is a prospective, multicenter, open-label, randomized controlled phase III trial conducted in three French cancer centers. This study addresses female adult patients with histologically confirmed, non-metastatic breast cancer, scheduled to receive neoadjuvant or adjuvant chemotherapy with epirubicin-cyclophosphamide (3 or 4 cycles) followed by either docetaxel (3 cycles) or paclitaxel (9–12 weekly cycles) as per routine practice. A total of 196 patients will be 1:1 randomized to automated scalp cooling device (experimental arm) or standard non-automated cold-cap therapy (control arm), with stratification on chemotherapy regimen, menopausal status and centre. The primary endpoint is the proportion of patients experiencing no more than half hair loss (NCI-CTCAE v5.0 grade 0–1) from baseline to chemotherapy completion, as assessed by blinded central review of standardized photographs. Secondary endpoints include: degree of CIA before taxane initiation; hair regrowth 6 months after the end of chemotherapy; patient adherence and comfort for each scalp cooling modality; body image (BIS); quality of life (EORTC QLQ-C30/BR23); anxiety/depression (HADS); satisfaction with care (OUTPATSAT-35-CT); return to work; nursing time associated with device use; and cost-utility in QALYs. Discussion This study will provide the first high-quality randomized evidence directly comparing scalp cooling and standard cold-cap use for CIA prevention in localized breast cancer. The results will inform both clinical practice and health policy by integrating clinical efficacy, patient-reported outcomes, and medico-economic considerations. Trial registration ClinicalTrials.gov NCT06011525
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