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| Sponsored by: |
Hospital San Carlos, Madrid |
| Information provided by: | Hospital San Carlos, Madrid |
| ClinicalTrials.gov Identifier: | NCT00515762 |
Purpose
Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. Docetaxel is toxic to skin and skin annexes and can produce nail toxicity and persistent alopecia. Nail toxicity has been successfully prevented by means of hypothermic gloves and slippers (Elasto-gel, Southwest Technologies, Inc, North Kansas City, MO). This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.
| Condition | Intervention | Phase |
|
Alopecia Breast Cancer |
Device: elasto-gel cap |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Hair Diseases and Hair Loss |
| ChemIDplus related topics: | Docetaxel |
| Study Type: | Interventional |
| Study Design: | Prevention, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: scalp cooling: Experimental
scalp cooling
|
Device: elasto-gel cap
scalp cooling cap
|
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: miguel martin, MD, PHD | +34-91-3303000 ext 3545 | mmartin@geicam.org |
| Spain | |||||
| Hospital Clinico San Carlos | Recruiting | ||||
| madrid, Spain, 28040 | |||||
| Contact: miguel martin, MD, PHD +34-91-3303000 ext 3546 mmartin@geicam.org | |||||
| Principal Investigator: miguel martin, MD, PHD | |||||
| Hospital San Carlos, Madrid |
| Principal Investigator: | miguel martin, MD, PHD | hospital clinico san carlos |
More Information
| Responsible Party: | Hospital San Carlos ( Miguel Martin, MD ) |
| Study ID Numbers: | ALOPER-2 |
| First Received: | August 13, 2007 |
| Last Updated: | May 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00515762 |
| Health Authority: | Spain: Spanish Agency of Medicines |
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