Axillary Web SyndromeNCT03284008
Assessing Efficacy of Axillary Web Syndrome Treatment
A study testing Manual manoeuver + stretching and stretching exercise in people with Axillary Web Syndrome, run by European Institute of Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Axillary Web Syndrome
- What is being tested?
- Manual manoeuver + stretching and stretching exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jul 2013to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Previous lymphedema.
- Bilateral axillary dissection surgery
- Physiotherapy treatment execute outside hospital during the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.
Read the 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.
- Conditions
- Axillary Web Syndrome
- Being tested
- Manual manoeuver + stretching, stretching exercise
- Keywords
- Breast Neoplasm, Physiotherapy, Rehabilitation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual manoeuver + stretchingOther
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 exerciseOther
Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.
| Study group | Role | What they receive |
|---|---|---|
| Manual manoeuver + stretching | Experimental | Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home. Receives: Other: Manual manoeuver + stretching |
| stretching exercise | Active comparator | Patients will receive education to perform stretching exercises at home. Receives: Other: stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion change overtime
Range of motion measured with a handheld goniometer, in degrees.
Measured: Baseline, 7 days and 30 days after baseline measure
Secondary outcomes (1)
Lymphedema assessment
Lymphedema measured with centimetric and constant dielectric method
Measured: 3 years after baseline measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start16 Jul 2013
- Primary completion12 Jan 2016
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Axillary Web SyndromeStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Umberto Veronesi
- Responsible party
- Sponsor
- Investigators
- Fabio Sandrin, Principal investigator, European Institute of Oncolgy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284008
- Sponsor's protocol ID
- IEO S721/412
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2017
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21987036Cheville 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.
PubMed 17457830Wariss 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.
PubMed 27704260Torres 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.
PubMed 19306057Moskovitz 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.
PubMed 11448437
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of Axillary Web Syndrome Treatment
- ClinicalTrials.gov ID
- NCT03284008
- Acronym / sponsor ID
- IEO S721/412
- Conditions
- Axillary Web Syndrome
- Keywords
- Breast Neoplasm, Physiotherapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Fondazione Umberto Veronesi
- Study start
- 16 Jul 2013 (actual)
- Primary completion
- 12 Jan 2016 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual manoeuver + stretching | Experimental | Other: Manual manoeuver + stretchingPatients will receive a manual manoeuver treatment and education to perform stretching exercises at home. |
| stretching exercise | Active comparator | Other: stretching exercisePatients will receive education to perform stretching exercises at home. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual manoeuver + stretchingPatients 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. | Other | Manual manoeuver + stretching |
| stretching exercisePatients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home. | Other | stretching exercise |
Primary outcome
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.
1 secondary outcome
Lymphedema assessment
Time frame: 3 years after baseline measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 21987036Bergmann 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.
- Background: PubMed 17457830Cheville 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.
- Background: PubMed 27704260Wariss 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.
- Background: PubMed 19306057Torres 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.
- Background: PubMed 11448437Moskovitz 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.
- Individual participant dataSharing planned: No
Related trials for Axillary Web Syndrome
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Effects of Muscle Energy Techniques With and Without Manual Axial Distraction in Post-Mastectomy Patients With Axillary Web Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Sandrin principal investigator
European Institute of Oncolgy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual manoeuver + stretching and stretching exercise in people with Axillary Web Syndrome, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion change overtime (time frame: Baseline, 7 days and 30 days after baseline measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284008, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.