Assessing Efficacy of Axillary Web Syndrome Treatment

Axillary Web Syndrome Clinical Trial

Official title:

Assessing Efficacy of Axillary Web Syndrome Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284008
• Other study ID #: IEO S721/412
• Status: Completed
• Phase: N/A
• Start date: July 16, 2013
• Est. completion date: January 30, 2019

Study information

• Verified date: July 2019
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.

Description:

Axillary Web Syndrome (AWS) is one of the short / medium-term sequela of surgical treatment for breast cancer with axillary dissection (AD) or sentinel lymph node biopsy (SLNB), with incidence reported in literature between 28% and 72%. AWS could be described as a thrombophlebitis of veno-lymph vessels due to a trauma of the region subjected to surgery, with the same characteristics of "Mondor's disease" diagnosed in post-traumatic and surgical areas where is a large presence of veno-lymphatic capillaries.

The syndrome onset occur in approximately 2-4 weeks after the surgery and its complete regression happen in 3-6 months after the onset. The clinical signs frequently described are pain and tension during movement in the axillary region, elbow, forearm and wrist, following the arm lymphatic pathway. Moreover, patients report difficulties in moving the arm into activities that require a moderate range of motion and could feel and see in the affected arm cords similar to a tendon. Even if the impairment can cause disability for a limited period of time, rehabilitation is usually advice to prevent further complications such as frozen shoulder, articular impeachment syndrome and long-term chronic pain, complications that could worsen patient's quality of life with a significant increase in costs and time to recovery.

Nowadays there are no studies in the literature that demonstrate the effectiveness of physiotherapy in AWS, with just case reports describing different treatments techniques, without a scientifically defined experimented rehabilitation protocol.

This experimental, monocentric, randomized clinical trial wants verify the effectiveness of a manual maneuver associated with stretching exercises in the treatment of AWS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2019
• Est. primary completion date: January 12, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female patients with age between 18 and 70 years old

• Axillary dissection with or without plastic reconstruction with prothesis

• Positive diagnose of axillary web syndrome.

• Patients without mental or psychological problems which could affect the proposed treatment execution.

• Signed informed consensus form.

Exclusion Criteria:

• Chronic or acute upper limb pathology which could affect the proposed treatment execution.

• Patients with mental or psychological problems which could affect the proposed treatment execution.

• Plastic reconstruction with abdominal (DIEP or TRAM) and dorsal grafts or with expander.

• Previous head and neck, sentinel lymph node biopsy or axillary dissection surgery.

• Previous breast, axillary or head and neck radiotherapy.

• Halsted mastectomy.

• Previous lymphedema.

• Bilateral axillary dissection surgery

• Physiotherapy treatment execute outside hospital during the study.

Related Conditions & MeSH terms

• Axillary Web Syndrome
• Syndrome

Intervention

Other:
• Manual manoeuver + stretching
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.
• stretching exercise
Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.

Locations

Country	Name	City	State
Italy	Istituto Europeo di Oncologia	Milano	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
European Institute of Oncology	Fondazione Umberto Veronesi

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. Review. — View Citation

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. — View Citation

Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sánchez MJ, Ferrandez JC, Zapico Goñi 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain change overtime	Pain measured with 0-10 numeric rate scale	Baseline, 7 days and 30 days after baseline measure
Primary	Range of motion change overtime	Range of motion measured with a handheld goniometer, in degrees.	Baseline, 7 days and 30 days after baseline measure
Secondary	Lymphedema assessment	Lymphedema measured with centimetric and constant dielectric method	3 years after baseline measure