Clinical trial · Observational
Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
NCT04117815CI-TRIAL-00056053completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia | — | UNRESOLVED | — |
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alopecia Assessments | Other | — | UNRESOLVED |
| Paxman Scalp Cooling System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- study group
- description
- Patients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line. Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen No alopecia of any reason (up-front) No overt cognitive impairment and fluent in German Written informed consent Age 18 and older
- interventionNames
- Device: Paxman Scalp Cooling System
- Other: Alopecia Assessments
- label
- reference group
- description
- For the purpose of comparison, a reference sample will be included in the study applying to the following inclusion criteria: Patients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line. Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen 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 Patients from the reference group complete the same survey as the study group. Group comparisons will be adjusted for baseline body image and reasons for refusal.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.