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ClinicalTrials.gov ID

NCT07474558

Lead Sponsor

Jules Bordet InstituteOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

102Estimated

Last Update Posted

Aug 19, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Jan 2030Estimated

Completion Date

Sep 2031Estimated

Official Title

SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates

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.

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

• scalp cooling
• photographs via the Belle.AI app
• Antibody-Drug Conjugates

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Known pregnant and/or lactating women.
2. 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
3. Active haematological malignancy diagnosis
4. Known or suspected scalp metastases at screening
5. Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)
6. History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria)
7. Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus)
8. Known hypersensitivity to device cap materials or coolant
9. Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement
10. 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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Jules Bordet InstituteOTHER

Collaborators

BelleTorus CorporationINDUSTRY

Gilead SciencesINDUSTRY

PaxmanUNKNOWN

donatienne.taylor@chuuclnamur.uclouvain.be