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Does hair curl variation influence the efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia in breast cancer patients? A randomised pilot trial

Does hair curl variation influence the efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia in breast cancer patients? A randomised pilot trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202104554144365
Enrollment
52
Registered
2021-04-14
Start date
2017-01-16
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Skin and Connective Tissue Diseases

Interventions

Chemotherapy with Scalp cooling

Sponsors

Nonhlanhla P Khumalo
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Female sex Age 18–65 years Removal of a breast cancer through mastectomy or breast conserving methods (with or without lymph node removal) < 12 weeks before inclusion Planned antineoplastic therapy with chemotherapy (Adriamycin and Cyclophosphamide followed by Paclitaxel) including written consent

Exclusion criteria

Exclusion criteria: Evidence of alopecia at baseline Planned radiation therapy of the skull before or during the study Antineoplastic therapy within 6 months prior to baseline Inadequately treated hypo or hyperthyroidism Known cold sensitivity, cold agglutinin disease, cryoglobulinemia and cryofibrinogenemia. Participation in another study. Unwillingness to participate in the study or withdrawal of consent before the first post treatment assessment. All post treatment data will be included in the analysis

Design outcomes

Primary

MeasureTime frame
To verify findings from previous research indicating that the severity of CIA is less in participants receiving scalp cooling versus those that are not, and to determine whether scalp cooling is less effective in patients with curly hair compared to those with straight hair.

Secondary

MeasureTime frame
To assess and establish procedures for recruitment and retention in a future study.

Countries

South Africa

Contacts

Public ContactNonhlanhla Khumalo

Head of the department of Dermatology

n.khumalo@uct.ac.za+27833915739

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026