Quantitative assessment of scalp cooling effect in chemotherapy induce alopecia

Phase 4

• Conditions: breast cancer; scalp cooling; alopecia; chemotherapy

• Registration Number: TCTR20171106002
• Lead Sponsor: Ratchadapiseksompotch Fund (Pending)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-06
• Study Completion: 2018-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1.Age 18-70 years old
2.CA breast patient who recieve one of the following chemotherapy regimen : oxorubicin cyclophosphamide or taxane-based regimen as neoadjuvant chemotherapy or adjuvant chemotherapy
3. At least 4 cycles of chemotherapy

Exclusion Criteria

1.History of previous chemotherapy treatment
2.Alopecia at least gr.I before receiving chemotherapy
3.History of migraine, hypothyroid, hepatitis, uncontrolled diabetes, cold intolerance, cryoglobulinemia, cryofibrinogenemia or cold agglutinin disease
4.History of iron deficiency anemia
5.History of oral contraceptive pill or hormone replacement therpary
6.History of psychological disorder diagnosed by psychiatrist
7.History of scalp disease
8.History of previous alopecia treatmenr
9.History of hair transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hair count after each chemotherapy cycle Hair scope

Secondary Outcome Measures

Name	Time	Method
Hair mass index after each chemotherapy cycle HairCheck instrument,Breast Cancer-Specific Quality of Life Questionnaire Items after each chemotherapy cycle Questionnaire,Hair follicle caspase-8, apoptotic (TUNEL+) cell, proliferation (Ki-67+) cell after 1 cycle chemotherapy biopsy and immunohistochemistry