NCT06269523

Brief Summary

Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

February 1, 2024

Last Update Submit

February 12, 2024

Conditions

Axillary Web Syndrome

Keywords

Axillary Web SyndromeKinesio tapingLymphatic drainageBreast cancer surgeryProprioceptive re-education

Outcome Measures

Primary Outcomes (3)

  • NRS Scale

    NRS scale is an 11-point unidimensional scale that evaluates the intensity of pain in adults.The scale is composed of a horizontal line, with an interval ranging from 0 to 10, corresponding respectively to "no pain" and "worst pain imaginable".

    one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery (t2)

  • Joint excursion shoulder

    Range of motion of the shoulder taken with the use of a goniometer

    one week after surgery(T0)-5 weeks after surgery(T1)- 12 weeks after surgery (t2)

  • Muscular strength of the upper limbs

    Distal strength can be semiquantitatively measured with a dynamometer. Dynamometry is a more precise measurement of the force that a muscle can exert and can allow for differences in strength to be recorded over time.

    one week after surgery(T0)- 5 weeks after surgery(T1) -12 weeks after surgery (t2)

Secondary Outcomes (2)

  • Constant Murley Score

    one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery(t2)

  • upper limbs circumferenze (cyrtometry)

    one week after surgery(T0)- 5 weeks after surgery(T1)- 12 weeks after surgery (t2)

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

18 sessions of functional and proprioceptive re-education, manual lymphatic drainage associated with kinesio taping.

Other: Kinesio taping, Lymphatic drainage

Control group

ACTIVE COMPARATOR

18 sessions of functional and proprioceptive re-education and manual lymphatic drainage.

Other: Lymphatic drainage

Interventions

Kinesio taping, Lymphatic drainageOTHER

Kinesio tape, is an elastic cotton strip with an acrylic adhesive that is purported to ease pain and disability from athletic injuries and a variety of other physical disorders. The application of Kinesio Tex Tape facilitates the opening of microvalves due to a dynamic pressure variation due to alteration in skin density. This decompression activates lymphatics in the dermis and improves lymphatic flow. The end result is a tissue inflammation and swelling reduction.It has been applied at the end over every session after lymphatic dreinage (see below).

Treatment group
Lymphatic drainageOTHER

Lymphatic drainage is a type of manual manipulation of the skin based on the hypothesis that it will encourage the natural drainage of the lymph, which carries waste products away from the tissues back toward the heart. The lymph system depends on intrinsic contractions of the smooth muscle cells in the walls of lymph vessels (peristalsis) and the movement of skeletal muscles to propel lymph through the vessels to lymph nodes and then to the lymph ducts, which return lymph to the cardiovascular system. Manual lymph drainage uses a specific amount of pressure and rhythmic circular movements to stimulate lymph flow.

Control group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women between the ages of 45 and 65 years with diagnosis of breast cancer underwent to quadrantectomy and axillary lymphadenectomy.

You may not qualify if:

  • metastatic disease, infections, past TVP, embolia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Palermo, 90127, Italy

Location

Related Publications (5)

  • 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: 11448437BACKGROUND

  • Agostini F, Attanasi C, Bernetti A, Mangone M, Paoloni M, Del Monte E, Mammucari M, Maggiori E, Russo D, Marzo RD, Migliore A, Paolucci T. Web Axillary Pain Syndrome-Literature Evidence and Novel Rehabilitative Suggestions: A Narrative Review. Int J Environ Res Public Health. 2021 Oct 2;18(19):10383. doi: 10.3390/ijerph181910383.

    PMID: 34639683BACKGROUND

  • Dinas K, Kalder M, Zepiridis L, Mavromatidis G, Pratilas G. Axillary web syndrome: Incidence, pathogenesis, and management. Curr Probl Cancer. 2019 Dec;43(6):100470. doi: 10.1016/j.currproblcancer.2019.02.002. Epub 2019 Mar 15.

    PMID: 30898366BACKGROUND

  • Ezzo J, Manheimer E, McNeely ML, Howell DM, Weiss R, Johansson KI, Bao T, Bily L, Tuppo CM, Williams AF, Karadibak D. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst Rev. 2015 May 21;2015(5):CD003475. doi: 10.1002/14651858.CD003475.pub2.

    PMID: 25994425BACKGROUND

  • Kasawara KT, Mapa JMR, Ferreira V, Added MAN, Shiwa SR, Carvas N Jr, Batista PA. Effects of Kinesio Taping on breast cancer-related lymphedema: A meta-analysis in clinical trials. Physiother Theory Pract. 2018 May;34(5):337-345. doi: 10.1080/09593985.2017.1419522. Epub 2018 Jan 8.

    PMID: 29308967BACKGROUND

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 21, 2024

Study Start

July 21, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2024

Last Updated

February 21, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT(1)