NCT03300349

Brief Summary

This study aims to determine the effectiveness of the different programmes of four Spanish hospitals about prevention of axillary lymphadenectomy sequels in breast cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

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

September 27, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

September 28, 2017

Last Update Submit

February 22, 2018

Conditions

Breast Cancer LymphedemaShoulder Injury

Keywords

Breast cancerBreast cancer-related lymphedemaShoulder injuryPreventionEducational activityPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • breast cancer-related lymphedema

    Truncated cone formula

    The agreed date with the participant for the evaluation (second half of 2017)

Secondary Outcomes (2)

  • functional shoulder limitation

    The agreed date with the participant for the evaluation (second half of 2017)

  • Symptoms associated with breast cancer-related lymphedema

    The agreed date with the participant for the evaluation (second half of 2017)

Other Outcomes (1)

  • Degree of compliance with the prevention program

    The agreed date with the participant for the evaluation (second half of 2017)

Study Arms (4)

axillary lymphadenectomy sequels

Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme

Other: Fulfillment of a preventive programmeOther: No fulfillment of a preventive programme

No axillary lymphadenectomy sequels

Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.

Other: Fulfillment of a preventive programmeOther: No fulfillment of a preventive programme

Fulfillment of a preventive programme

Patients who fulfil a preventive programme for axillary lymphadenectomy sequels

No fulfillment of a preventive programme

Patients who do not fulfil a preventive programme for axillary lymphadenectomy sequels

Interventions

Fulfillment of a preventive programmeOTHER

Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

No axillary lymphadenectomy sequelsaxillary lymphadenectomy sequels
No fulfillment of a preventive programmeOTHER

No fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

No axillary lymphadenectomy sequelsaxillary lymphadenectomy sequels

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women suffering from axillary lymphadenectomy due to breast cancer in four spanish hospitals

You may qualify if:

  • Suffering from axillary lymphadenectomy due to breast cancer treatment between 1 january 2014 until 31 december 2016.

You may not qualify if:

  • Lymphedema prior to surgery in any of the upper limbs or any malformation or injury that prevents comparison of both upper limb volumes.
  • Cognitive impairment or intellectual disability that would prevent understanding the instructions of the study, as well as the purpose of the same.
  • Serious condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Complejo Hospitalario Universitario de Cartagena

Cartagena, Murcia, 30203, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Castilla-La Mancha University

Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Breast Cancer LymphedemaShoulder InjuriesBreast Neoplasms

Condition Hierarchy (Ancestors)

LymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Violeta Pajero Otero, MRes

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist at the Mammary Pathology Unit

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 3, 2017

Study Start

September 27, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(5)