Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy

CompletedOBSERVATIONAL
Enrollment

128

Participants

Timeline

Start Date

May 18, 2018

Primary Completion Date

April 30, 2020

Study Completion Date

February 28, 2021

Conditions
Breast Cancer FemaleAlopecia
Interventions
DEVICE

Paxman Scalp Cooling System

"All patients who accomplish inclusion criteria and do not exhibit any contraindication undergo scalp cooling with the following conditions:~* Minimum 30 minutes pre-infusion cooling~* Cooling for the duration of chemotherapy infusion~* Minimum 90 minutes post-infusion cooling Scalp cooling is performed within the study group at each CT session."

OTHER

Alopecia Assessments

"Patients (study group and reference group) will be assessed at the following time Points:~* Baseline~* at the half-way Point of the cyles~* at the last CT cycle~* 3 months after completion of Treatment~* 6-9 months after treatment completion~The assesments include the following~* Photographs of the head, which are evaluated using the CTCAEv4.0~* Questionnaire including the NCI- PRO-CTCAE-ITEMS, EORTC QLQ-C30, EORTC QLQ-B23, Body Image Scale, PRO-CTACAEs and Hairdex questionnaire"

Trial Locations (1)

6020

Medical University Innsbruck, Department of Gynaecology and Obstetrics, Innsbruck

All Listed Sponsors
lead

Medical University Innsbruck

OTHER

NCT04117815 - Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy | Biotech Hunter | Biotech Hunter