CompletedNCT03300349Updated Feb 23, 2018

Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.

An observational study in Breast Cancer Lymphedema and Shoulder Injury, sponsored by Violeta Pajero Otero. Completed at 5 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Violeta Pajero Otero · Observational

Study type: Observational
Model: Case-control
Time perspective: Retrospective
Enrollment: 276
Ages: 18 Years and older
Sex: Female

Study 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.

Read the detailed description

This study aims to describe the different programs for the prevention of sequels of axillary lymphadenectomy in patients with breast cancer in four Spanish hospitals, to determine the degree of compliance of these programs and to register the frecuency of lymphedema and limitation of mobility of the upper limb in breast cancer patients undergoing axillary lymphadenectomy between 2014 and 2016 in the four hospitals.

Conditions studied

Breast Cancer Lymphedema
Shoulder Injury

Browse trials for

Keywords

Breast cancer
Breast cancer-related lymphedema
Shoulder injury
Prevention
Educational activity
Physiotherapy

In context

Breast Cancer Lymphedema

151 studies on the registry are indexed under Breast Cancer Lymphedema; 45 are open to participants now.

This study's enrollment of 276 is above the median of 74 across 29 observational studies indexed under Breast Cancer Lymphedema.

Browse Breast Cancer Lymphedema studies →

Lead sponsor

Violeta Pajero Otero is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Case-control
Time perspective: Retrospective
Enrollment: 276 participants (actual)
Patient registry: No

Groups and cohorts

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 programme · Other: 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 programme · Other: 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

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

What researchers measure

Primary outcomes

breast cancer-related lymphedema
Truncated cone formula
Time frame: The agreed date with the participant for the evaluation (second half of 2017)

Secondary outcomes

functional shoulder limitation
Shoulder Pain and Disability Index
Time frame: The agreed date with the participant for the evaluation (second half of 2017)
Symptoms associated with breast cancer-related lymphedema
Visual Analogic Scale
Time frame: The agreed date with the participant for the evaluation (second half of 2017)

Other outcomes

Degree of compliance with the prevention program
questionnaire
Time frame: The agreed date with the participant for the evaluation (second half of 2017)

Study locations

5 sites

Hospital Universitario Puerta de Hierro
Majadahonda, Madrid 28222, Spain
Complejo Hospitalario Universitario de Cartagena
Cartagena, Murcia 30203, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Castilla-La Mancha University
Toledo, 45071, Spain

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Dec 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 28, 2017
First posted: Oct 3, 2017
StartActual: Sep 27, 2017
Primary completionActual: Dec 31, 2017
CompletionActual: Dec 31, 2017
Last update: Feb 23, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03300349
Lead sponsor: Violeta Pajero Otero
Collaborators: Hospital Universitario 12 de Octubre, University of Castilla-La Mancha, Puerta de Hierro University Hospital, Complejo Hospitalario Universitario de Cartagena
Responsible party: Violeta Pajero Otero (Physiotherapist at the Mammary Pathology Unit, Hospital Universitario 12 de Octubre) — Sponsor-investigator
First posted: Oct 3, 2017
Start date: Sep 27, 2017
Primary completion: Dec 31, 2017
Completion: Dec 31, 2017
Last update: Feb 23, 2018

Study contacts

Violeta Pajero Otero, MRes

principal investigator · Hospital Universitario 12 de Octubre

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Cancer Lymphedema →

Other studies from this sponsor

Violeta Pajero Otero

Start the discussion