Horse Chestnut Seed Extract for Lymphedema
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 06/30/2011 |
| Pirmasis pateikimas: | 09/12/2005 |
| Numatytas registravimas pateiktas: | 09/12/2005 |
| Pirmas paskelbtas: | 09/20/2005 |
| Paskutinis atnaujinimas pateiktas: | 05/28/2015 |
| Paskutinis atnaujinimas paskelbtas: | 06/01/2015 |
| Faktinė studijų pradžios data: | 04/30/2002 |
| Numatoma pirminio užbaigimo data: | 08/31/2004 |
| Numatoma studijų užbaigimo data: | 08/31/2008 |
Būklė ar liga
Intervencija / gydymas
Drug: Horse Chestnut Seed Extract
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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 |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 17 Years Į 17 Years |
| Tinkamos studijoms lytys | Female |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. Reduction of arm lymphedema [undefined]
Antrinės rezultatų priemonės
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]
