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

NCT04117815 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2022-01-20

No results posted yet for this study

Summary

Chemotherapy (CT) is a frequent and well established treatment in women with breast and gynecological tumors. Alopecia is one of the most common side effects of CT seriously impairing patient quality of life and body image. While other CT associated side effects can be controlled by supportive treatment strategy, adequate preventive measures for alopecia have been lacking. New evidence supports the efficacy of scalp cooling for alopecia prevention during CT.

Conditions

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

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Christian Marth, Prof Dr · Medical University Innsbruck

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-18
Primary Completion
2020-04-30
Completion
2021-02-28
FDA Device
Yes

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04117815 on ClinicalTrials.gov