SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates

Обзор

The goal of this interventional study is to determine if scalp cooling (by the Paxman Scalp Cooling System) reduces the extent and severity of alopecia in participants with advanced solid tumours receiving ADC. The main question it aims to evaluate the efficacy of scalp cooling in reducing chemotherapy-induced alopecia in participants with advanced/metastatic solid tumours receiving antibody-drug conjugates (trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan), as assessed by blinded central dermatological review. Researchers will compare the experimental arm (ADC treatment + scalp cooling) with the control arm (ADC only). Scalp cooling will be done each day of ADC treatment : before, during and post-infusions of their ADC treatment.

Вмешательства

• Устройство scalp cooling
  scalp cooling at -10°C for each cycle of ADC, subjects will ubdergo scalp cooling : 30 minutes prior ADC treatment, during ADC treatment and 90 minutes following ADC treatment
• Другое photographs via the Belle.AI app
  artificial intelligence-based software tool designed for standardised photographic documentation and automated assessment of alopecia severity using the Severity of Alopecia Tool (SALT) scale generated AI Score will be blinded for investigator and patient outcome does not impact treatment of the subject
• Препарат Antibody-Drug Conjugates
  study will randomize female participants receiving one of the following ADCs as part of their standard-of-care treatment: sacituzumab-govitecan, trastuzumab-deruxtecan, or datopotamab-deruxtecan.

Первичные конечные точки

• percentage of participants with hair loss [Срок оценки: 3 months]

Вторичные конечные точки (5)

• degree of hair loss [Срок оценки: 3 months]
• Change from baseline in quality of life [Срок оценки: at each cycle of treatment + 28 days following end of treatment]
• Change from baseline in quality of life [Срок оценки: at each cycle of treatment + 28 days after the end of treatment]
• Frequency, and severity of adverse events related to scalp cooling [Срок оценки: all along study : from first day of treatment until 6 months follow up after the last administration of study treatment or before starting any new anticancer treatment, whichever comes first]
• compare scalp hair loss assessment across three methods [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Female
• Age ≥ 18 years
• ECOG performance status (PS) 0-2
• Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE < 2)
• Participants with histologically or cytologically confirmed advanced or metastatic solid tumour
• Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule
• Life expectancy > 6 months
• Signed Informed Consent form (ICF) obtained prior to any study related procedure.
• Participant is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations

Критерии исключения

• Known pregnant and/or lactating women.
• Participant with a known significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
• Active haematological malignancy diagnosis
• Known or suspected scalp metastases at screening
• Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)
• History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria)
• Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus)
• Known hypersensitivity to device cap materials or coolant
• Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement
• Participants who have already started treatment with an ADC prior to randomisation will be excluded, as scalp cooling must begin with the first ADC infusion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Бельгия · 2 центра

• Institut Jules Bordet — Anderlecht
• CHU UCL Namur Site Sainte Elisabeth — Namur

Идентификаторы

NCT: NCT07474558 · IJB-SCARLET-ICE-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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