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| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2007 | ||||
| Last Updated Date | May 14, 2008 | ||||
| Start Date ICMJE | May 2007 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
percentage of patients without persistent alopecia [ Time Frame: 2nd year following docetaxel chemotherapy ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
percentage of patients without persistent alopecia [ Time Frame: 2nd year following docetaxel chemotherapy ] | ||||
| Change History | Complete list of historical versions of study NCT00515762 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling | ||||
| Official Title ICMJE | Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: elasto-gel cap | ||||
| Study Arms / Comparison Groups | Experimental: scalp cooling | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00515762 | ||||
| Responsible Party | Miguel Martin, MD, Hospital San Carlos | ||||
| Study ID Numbers ICMJE | ALOPER-2 | ||||
| Study Sponsor ICMJE | Hospital San Carlos, Madrid | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hospital San Carlos, Madrid | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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