NCT03284008|Completed
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Sponsor study identifier
interventional
60
1 country
1
Study Start
July 16, 2013
Actual (reported)Primary Completion
January 12, 2016
Actual (reported)Study Completion
January 30, 2019
Actual (reported)The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2013
Actual (reported)January 12, 2016
Actual (reported)July 25, 2017
Actual (reported)September 15, 2017
Actual (reported)January 30, 2019
Actual (reported)Range of motion change overtime
Range of motion measured with a handheld goniometer, in degrees.
Baseline, 7 days and 30 days after baseline measure
Lymphedema assessment
3 years after baseline measure
Pain change overtime
Baseline, 7 days and 30 days after baseline measure
Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home.
Patients will receive education to perform stretching exercises at home.
Patients in experimental group will receive, after AWS diagnose, a manual manoeuver to snap the cord, follow by a demonstration and education of the exercise to be made at home.
Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.
Istituto Europeo di Oncologia
Milan, Lombardy, 20141, Italy
Bergmann A, Mendes VV, de Almeida Dias R, do Amaral E Silva B, da Costa Leite Ferreira MG, Fabro EA. Incidence and risk factors for axillary web syndrome after breast cancer surgery. Breast Cancer Res Treat. 2012 Feb;131(3):987-92. doi: 10.1007/s10549-011-1805-7. Epub 2011 Oct 11.
Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.
Fabio Sandrin
European Institute of Oncolgy
60 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2017
First Posted
September 15, 2017
Study Start
July 16, 2013
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Wariss BR, Costa RM, Pereira AC, Koifman RJ, Bergmann A. Axillary web syndrome is not a risk factor for lymphoedema after 10 years of follow-up. Support Care Cancer. 2017 Feb;25(2):465-470. doi: 10.1007/s00520-016-3424-7. Epub 2016 Oct 4.
Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.
Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9. doi: 10.1016/s0002-9610(01)00602-x.
Primary Completion
January 12, 2016
Actual (reported)Study Completion
January 30, 2019
Actual (reported)Last Updated
July 17, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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