Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
Recruitment status was Recruiting
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| First Received Date ICMJE | February 13, 2009 | ||||||||
| Last Updated Date | February 13, 2009 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Aesthetic breast scores [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer | ||||||||
| Official Title ICMJE | Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer | ||||||||
| Brief Summary | This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study. The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation. |
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| Detailed Description | Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10) We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 144 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00845078 | ||||||||
| Other Study ID Numbers ICMJE | PRO07120002 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Julio A. Clavijo-Alvarez/ MD, University of Pittsburgh | ||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | February 2009 | ||||||||
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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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