Horse Chestnut Seed Extract for Lymphedema
Ключавыя словы
Рэферат
Апісанне
The objectives of this study are to evaluate the effectiveness of escin (as horse chestnut seed extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedance as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.
Даты
| Апошняя праверка: | 06/30/2011 |
| Упершыню прадстаўлена: | 09/12/2005 |
| Меркаваная колькасць заявак прадстаўлена: | 09/12/2005 |
| Першае паведамленне: | 09/20/2005 |
| Апошняе абнаўленне адпраўлена: | 05/28/2015 |
| Апошняе абнаўленне апублікавана: | 06/01/2015 |
| Фактычная дата пачатку даследавання: | 04/30/2002 |
| Разліковая дата першаснага завяршэння: | 08/31/2004 |
| Разліковая дата завяршэння даследавання: | 08/31/2008 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Drug: Horse Chestnut Seed Extract
Фаза
Групы ўзбраенняў
| Рука | Ўмяшанне / лячэнне |
|---|---|
| No Intervention: Control | |
| Active Comparator: Horse Chestnut Seed Extract Horse chestnut seed extract (escins, aesins) | Drug: Horse Chestnut Seed Extract Control (no intervention) vs Horse Chestnut Seed Extract |
Крытэрыі прыдатнасці
| Узрост, які мае права на вучобу | 17 Years Каб 17 Years |
| Пол, прыдатны для навучання | Female |
| Прымае здаровых валанцёраў | Так |
| Крытэрыі | Inclusion Criteria: - Patient demonstrates unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity. An extravascular water ratio of ³1.1/1 between the affected vs normal arm using multiple-frequency bioelectric impedance will be used as a criterion for lymphedema. There is not upper limit to the extent of arm volume (lymphedema) - Patient is greater than 6 months from last surgical and/or radiation treatment to the affected axilla. Exclusion Criteria: - Patients may not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this lymphedema study (Last chemotherapy > 4 weeks prior). Women who are being treated adjuvantly with tamoxifen, raloxifene, or an aromatase inhibitor remain eligible - Patients with a history of recurrent (more than 1 episode) arm cellulitis, prior or existing venous clot, or considered to have "woody" fibrosis of the affected arm are not eligible. Antibiotics used to treat any prior episode of cellulitis must have be completed no more recently than 3 months prior to initial screening. |
Вынік
Першасныя вынікі
1. Reduction of arm lymphedema [undefined]
Меры другаснага выніку
1. - comparison of bioelectric impedance to measure lymphedema changes [undefined]
2. - validation of bioelectric impedance to measure lymphedema changes [undefined]
3. - validation of lymphedema questionnaire [undefined]
