Status:
COMPLETED
Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Paxman
Conditions:
Neoplasm, Breast
Eligibility:
FEMALE
20-69 years
Phase:
NA
Brief Summary
This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. Female adults who are n...
Detailed 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 man...
Eligibility Criteria
Inclusion
- 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)
- For the additional single arm, patients who expected to receive 4, 6, or 8 cycles of Adriamycin or Taxance chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, TCHP, or AC+T).
Exclusion
- 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
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04678544
Start Date
December 23 2020
End Date
August 30 2022
Last Update
November 5 2024
Active Locations (1)
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1
Samsung Medical Center, Ilwon-ro 81, Gangnam-gu
Seoul, South Korea, 06351