SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates

NCT07474558 | Not Yet Recruiting Phase 2

• 1 other identifier: IJB-SCARLET-ICE-2025
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced or Metastatic Solid Tumour; Antibody-Drug Conjugate; Alopecia

Keywords

ADC; Antibody-drug conjugates; advanced or metastatic solid tumour; scalp cooling; hair loss; alopecia

Outcome Measures

Primary Outcomes (1)

• percentage of participants with hair loss

  defined as the Severity of Alopecia Tool (SALT) score greater than zero The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.). 3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss. assessed by blinded central dermatological review.

  3 months

Secondary Outcomes (5)

• degree of hair loss

  3 months

• Change from baseline in quality of life

  at each cycle of treatment + 28 days following end of treatment

• Change from baseline in quality of life

  at each cycle of treatment + 28 days after the end of treatment

• Frequency, and severity of adverse events related to scalp cooling

  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

  3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Scalp cooling

Device: scalp cooling; Other: photographs via the Belle.AI app; Drug: Antibody-Drug Conjugates

Control

OTHER

Observation

Other: photographs via the Belle.AI app; Drug: Antibody-Drug Conjugates

Interventions

scalp cooling DEVICE

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

Experimental

photographs via the Belle.AI app OTHER

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

Control; Experimental

Antibody-Drug Conjugates DRUG

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.

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead
• BelleTorus Corporation: collaborator
• Gilead Sciences: collaborator
• Paxman: collaborator

Study Sites (2)

Institut Jules Bordet

Anderlecht, Brussels Capital, 1070, Belgium

Location

CHU UCL Namur Site Sainte Elisabeth

Namur, Belgium

Location

MeSH Terms

Conditions

Alopecia

Interventions

Immunoconjugates

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Evandro de Azambuja, MD PhD

  Medical oncologist

  STUDY CHAIR

Central Study Contacts

Evandro de Azambuja Medical oncologist, Study Chair, MD PhD

CONTACT

+32 2 541 7244; evandro.deazambuja@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Dermatologists Committee who will centrally assess alopecia (providing SALT score)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, controlled, multi-centric clinical investigation designed to evaluate the efficacy and safety of scalp cooling in preventing CIA in participants with advanced or metastatic solid tumours treated with "new" ADC. The study will compare scalp cooling versus observation (no cooling) in a 1:1 randomisation, stratified by type of ADC used (T-DXd, SG or Dato-DXd) and previous alopecia (yes vs. no). The 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. Scalp cooling, with the coolant at -10ºC, will be applied prior to, during, and after each ADC infusion using the Paxman Scalp Cooling System. The intervention will continue until one of the following, whichever occurs first: unacceptable scalp cooling-related toxicity, discontinuation of the ADC for any reason, or a maximum of six months of treatment.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: March 16, 2026

Record last verified: 2026-02

Locations

BE (2)