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Primary objective:
Secondary objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
| |
| C | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paxman Cooling Machine | Device | Scalp cooling procedures |
| |
| Cold Caps |
| Measure | Description | Time Frame |
|---|---|---|
| Grade III or IV alopecia according to the WHO criteria | D1 of each cycle and D+21 after last cycle of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to scalp cooling procedure | D1 of each cycle and D+21 after last cycle of chemotherapy | |
| Side effects of scalp cooling systems | D1 of each cycle and D+21 after last cycle of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Geneva | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23636645 | Derived | Betticher DC, Delmore G, Breitenstein U, Anchisi S, Zimmerli-Schwab B, Muller A, von Moos R, Hugli-Dayer AM, Schefer H, Bodenmann S, Buhler V, Trueb RR. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Device |
Scalp cooling procedures |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |