Scalp cooling to prevent hair loss induced due to chemotherapy in breast cancer

Phase 2

• Conditions: Health Condition 1: null- Breast Cancer

• Registration Number: CTRI/2017/02/007896
• Lead Sponsor: Access Devices

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•New diagnosis of non-metastatic breast cancer

•Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent

•Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen,

•Defined as one of the following regimens:

ï??EC (Epirubicin 90mg/m2) & (Cyclophosphamide 600 mg/m2) or FEC (5Florouracil 500 mg/m2, Epirubicin 90mg/m2 & Cyclophosphamide 500 mg/m2 x 4 cycles

ï??Followed by weekly Paclitaxel (80mg/m2) x 12 weeks or 3 weekly Paclitaxel (175 mg/m2) or Docetaxel (100 mg/m2) x 4 cycles

•Concurrent trastuzumab at standard doses is allowed.

•Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.

Exclusion Criteria

•Metastatic breast cancer

•Baseline alopecia (defined CTCAE v4.0 grade > 0, see Appendix B)

•Subjects with cold agglutinin disease or cold urticaria.

•Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)

•Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator.

•Subjects who have lichen, planus or lupus.

•Subjects who have had previous chemotherapy exposure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified