Clinical trial NCT03284008: Assessing Efficacy of Axillary Web Syndrome Treatment
Official title: Assessing Efficacy of Axillary Web Syndrome Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axillary Web Syndrome
Keywords: Breast Neoplasm
Physiotherapy
Rehabilitation
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Fondazione Umberto Veronesi
First posted: 2017-09-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Range of motion change overtime
timeFrame: Baseline, 7 days and 30 days after baseline measure
Secondary outcomes:
measure: Lymphedema assessment
timeFrame: 3 years after baseline measure
Other outcomes:
measure: Pain change overtime
timeFrame: Baseline, 7 days and 30 days after baseline measure
Locations:
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: Lombardia
Study officials:
affiliation: European Institute of Oncolgy
name: Fabio Sandrin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: 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.
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. doi: 10.1016/s0002-9610(01)00602-x.