Assessing Efficacy of Axillary Web Syndrome Treatment

NCT03284008 | Completed

• 1 other identifier: IEO S721/412
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Axillary Web Syndrome

Keywords

Breast Neoplasm; Physiotherapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lymphedema assessment

  3 years after baseline measure

Other Outcomes (1)

• Pain change overtime

  Baseline, 7 days and 30 days after baseline measure

Study Arms (2)

Manual manoeuver + stretching

EXPERIMENTAL

Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home.

Other: Manual manoeuver + stretching

stretching exercise

ACTIVE COMPARATOR

Patients will receive education to perform stretching exercises at home.

Other: stretching exercise

Interventions

Manual manoeuver + stretching OTHER

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.

Manual manoeuver + stretching

stretching exercise OTHER

Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.

stretching exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead
• Fondazione Umberto Veronesi: collaborator

Study Sites (1)

Istituto Europeo di Oncologia

Milan, Lombardy, 20141, Italy

Location

Related 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.

  PMID: 21987036 BACKGROUND

• 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.

  PMID: 17457830 BACKGROUND

• 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.

  PMID: 27704260 BACKGROUND

• 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.

  PMID: 19306057 BACKGROUND

• 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.

  PMID: 11448437 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fabio Sandrin

  European Institute of Oncolgy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: September 15, 2017
• Study Start: July 16, 2013
• Primary Completion: January 12, 2016
• Study Completion: January 30, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)