Status:
COMPLETED
Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
Lead Sponsor:
Medical University Innsbruck
Conditions:
Breast Cancer Female
Alopecia
Eligibility:
FEMALE
18-99 years
Brief 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 ...
Detailed Description
Scalp cooling using cooling caps has been identified as an effective treatment option against CT-induced alopecia in numerous European countries. Originally, crashed ice was used to cause vasoconstric...
Eligibility Criteria
Inclusion
- Patients with breast or gynecological cancer planning to undergo CT
- CT can be neoadjuvant, adjuvant or palliative
- Up to two lines of CT are allowed. Adjuvant therapy counts as one line
- CT regime is associated with alopecia
- CT must be planned for at least 4 cycles of taxane or anthracyline-based CT regimen
- written informed consent age 18 and older
Exclusion
- Migraine
- Cold allergy/Cold Agglutinins/Morbus Raynaud
- Hematological malignancies (Leukemia, non Hodgkins and other generalized lymphomas)
- Manifest scalp metastases
- Overt cognitive impairment
- Insufficient knowledge of German language
- Reference Population:
- Patients with breast or gynecological cancer planning to undergo CT
- CT can be adjuvant, neoadjuvant or palliative
- up to two lines of CT are allowed. Adjuvant therapy counts as one line.
- CT regime is associated with alopecia
- CT must be planned for at least 4 cycles of taxane or anthracycline-based CT regime
- Refuse to undergo scalp cooling
- Patients who have been excluded for the study group for the reason of migraine
- written informed consent
- age 18 and older
Key Trial Info
Start Date :
May 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04117815
Start Date
May 18 2018
End Date
February 28 2021
Last Update
January 20 2022
Active Locations (1)
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1
Medical University Innsbruck, Department of Gynaecology and Obstetrics
Innsbruck, Tyrol, Austria, 6020