Assessing Efficacy of Axillary Web Syndrome Treatment

July 16, 2019 updated by: European Institute of Oncology
The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo Di Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual manoeuver + stretching
Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home.
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.
Active Comparator: stretching exercise
Patients will receive education to perform stretching exercises at home.
Other: stretching exercise
Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion change overtime
Time Frame: Baseline, 7 days and 30 days after baseline measure
Range of motion measured with a handheld goniometer, in degrees.
Baseline, 7 days and 30 days after baseline measure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymphedema assessment
Time Frame: 3 years after baseline measure
Lymphedema measured with centimetric and constant dielectric method
3 years after baseline measure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain change overtime
Time Frame: Baseline, 7 days and 30 days after baseline measure
Pain measured with 0-10 numeric rate scale
Baseline, 7 days and 30 days after baseline measure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Collaborators

Fondazione Umberto Veronesi

Investigators

  • Principal Investigator: Fabio Sandrin, European Institute of Oncolgy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2013

Primary Completion (Actual)

January 12, 2016

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO S721/412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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