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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 - Trial PACTR202104554144365

Access comprehensive clinical trial information for PACTR202104554144365 through Pure Global AI's free database. This Phase 3 trial is sponsored by Nonhlanhla P Khumalo and is currently Completed. The study focuses on Cancer; Skin and Connective Tissue Diseases.

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PACTR202104554144365
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Completed
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Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202104554144365
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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

Study Focus

device

Sponsor & Location

Nonhlanhla P Khumalo

The NRF SARChI Chair in Dermatology and Toxicology ; The South African Medical Research Council.

South Africa

Timeline & Enrollment

Phase 3

May 01, 2017

Nov 30, 2018

Summary

BackgroundChemotherapeutic agents are commonly administered as a treatment for breast cancer. They work by damaging rapidly dividing cells such as cancer cells with an unintended effect on other normal cells such as hair follicles, which may result in alopecia. Chemotherapy-induced alopecia (CIA), although reversible, has been described as one of the most common and distressing side effects of cancer therapy, affecting approximately 65% of all patients and influencing treatment decisions in some women who want to avoid hair loss. Scalp cooling devices have been proven effective in reducing CIA. However, It is not clear from published literature, results of which are derived mainly from patients with straight hair, whether these results are generalisable to patients with curlier hair types. Results of a Dutch scalp cooling registry comprising of 1411 patients showed this intervention to be effective in 50% of patients. Although a multivariate analysis failed to show that hair type had an impact on efficacy, it is noteworthy that patients with โ€˜African hairโ€™ type constituted only 1% of the registry. In a randomised prospective clinical study, the Scalp Cooling Alopecia Prevention (SCALP) trial, the cooling system was significantly more likely to cause less hair loss. In this trial, although no multivariate analysis by hair type is stipulated, demographic information shows that only 12% of the study population was Black or African American. In another prospective study, the use of scalp cooling was associated with less hair loss after chemotherapy. In this study, as with previous trials, Black women constituted a minority of the study population with only 10.4% representation.Objectives In this pilot trial, the research aims were to assess feasibility of conducting a definitive trial and to evaluate whether hair curvature influences the ability of scalp cooling to reduce chemotherapy-induced hair loss in breast cancer patients. The primary objectives of the stu

ICD-10 Classifications

Diseases of the skin and subcutaneous tissue
Systemic disorders of connective tissue in diseases classified elsewhere
Systemic disorders of connective tissue in other diseases classified elsewhere
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Other disorders of the skin and subcutaneous tissue

Data Source

Pan Africa Clinical Trials Registry

PACTR202104554144365

Device Trial