Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients

  • STATUS
    Recruiting
  • End date
    Feb 20, 2023
  • participants needed
    170
  • sponsor
    Samsung Medical Center
Updated on 20 August 2021
taxane
adjuvant chemotherapy
adriamycin

Summary

This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. Female adults who are newly diagnosed with stage 1-3 breast cancer and expected to receive Adriamycin or/and Taxane will participate in the study. The study design is a open label, randomized controlled trial. The patients will be randomly assigned to intervention or control groups. Intervention patients will have applied scalp cooling during 4 or 6 cycles of their chemotherapy. Primary endpoint is the effectiveness of the PSCS2 for reducing permanent chemotherapy-induced alopecia. Secondary endpoints include chemotherapy-induced alopecia, distress due to chemotherapy induced alopecia, quality of life, and patient-reported alopecia related side effect.

Description

Adjuvant chemotherapy decreases the risk of recurrence. However, it has distressing side effects, including alopecia. Chemotherapy-induced alopecia (CIA) is a common and distressing side effect of many chemotherapy drugs. In previous study, more than half of the breast cancer patients experienced higher distress due to CIA during cancer treatment, and this distress was strongly associated with negative body image, overall health status, and psychosocial well-being. Recently scalp cooling has been known to be one of the effective options for hair loss prevention. However there was little information regarding the effect on prevention of permanent CIA(PCIA). This study aims to examine the impact of scalp cooling on prevention of PCIA as well as CIA.

Female adults who are newly diagnosed with stage 1-3 breast cancer and aged less than 70 years will be screened for plan of undergoing Adriamycin or/and Taxane regimen as neoadjuvant or adjuvant chemotherapy. Eligible patients will be randomly assigned to intervention or control groups (2:1 ratio). Patients in intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in control group will be observed.

The objective of the study is to examine whether Paxman scalp cooling system is effective in reducing PCIA in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. In addition, impact of Paxman scalp cooling on prevention of CIA, alopecia-related distress, quality of life and patient-reported alopecia related side effect will be also explored.

Details
Condition tumor of the breast, breast tumors, breast tumor, Breast Cancer
Treatment Scalp cooling system 2
Clinical Study IdentifierNCT04678544
SponsorSamsung Medical Center
Last Modified on20 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Newly diagnosed breast cancer, stage I-III
Expected to receive 4 or 6 cycles of Adriamycin or Taxance of chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, or TCHP)

Exclusion Criteria

Any other concurrent malignancy including hematological malignancies
Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
Serum Albumin < 3.0
Subjects who are underweight (defined as a BMI < 17.5)
Subjects who have had previous chemotherapy exposure
Subjects with cold agglutinin disease or cold urticarial
Subject who had thyroid disease, diabetes or cardiac disease
Subject who had auto-immune disease
History of treatment due to alopecia
Subject who had scalp disease
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