Breast Cancer LymphedemaNCT03300349
Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.
An observational study of Breast Cancer Lymphedema and Shoulder Injury, run by Violeta Pajero Otero at 5 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema, Shoulder Injury
- What is being tested?
- Fulfillment of a preventive programme and No fulfillment of a preventive programme
- How many people
- 276 participants
- Where
- 5 sitesSpain
- Study dates
- 27 Sep 2017to 31 Dec 2017
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women suffering from axillary lymphadenectomy due to breast cancer in four spanish hospitals
Who may be able to join
- Suffering from axillary lymphadenectomy due to breast cancer treatment between 1 january 2014 until 31 december 2016.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Complejo Hospitalario Universitario de Cartagena
Cartagena, Murcia, 30203
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Castilla-La Mancha University
Toledo, 45071
About this study
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
- Breast Cancer Lymphedema, Shoulder Injury
- Being tested
- Fulfillment of a preventive programme, No fulfillment of a preventive programme
- Keywords
- Breast cancer, Breast cancer-related lymphedema, Shoulder injury, Prevention, Educational activity, Physiotherapy
- Medical subject headings
- Breast Cancer Lymphedema, Shoulder Injuries, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulfillment of a preventive programmeOther
Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast cancer-related lymphedema
Truncated cone formula
Measured: The agreed date with the participant for the evaluation (second half of 2017)
Secondary outcomes (2)
functional shoulder limitation
Shoulder Pain and Disability Index
Measured: The agreed date with the participant for the evaluation (second half of 2017)
Symptoms associated with breast cancer-related lymphedema
Visual Analogic Scale
Measured: The agreed date with the participant for the evaluation (second half of 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start27 Sep 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Violeta Pajero Otero
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, University of Castilla-La Mancha, Puerta de Hierro University Hospital, Complejo Hospitalario Universitario de Cartagena
- Responsible party
- Sponsor-investigator, Violeta Pajero Otero, Hospital Universitario 12 de Octubre
- Investigators
- Violeta Pajero Otero, MRes, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300349
- Sponsor's protocol ID
- InveCuidRh001
- Status last verified
- Feb 2018
- First submitted
- 28 Sep 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT03300349
- Acronym / sponsor ID
- InveCuidRh001
- Conditions
- Breast Cancer Lymphedema, Shoulder Injury
- Keywords
- Breast cancer, Breast cancer-related lymphedema, Shoulder injury, Prevention, Educational activity, Physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Violeta Pajero OteroUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, University of Castilla-La Mancha, Puerta de Hierro University Hospital, Complejo Hospitalario Universitario de Cartagena
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Oct 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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| axillary lymphadenectomy sequels | – | Other: Fulfillment of a preventive programme, Other: No fulfillment of a preventive programmePatients 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 |
| No axillary lymphadenectomy sequels | – | Other: Fulfillment of a preventive programme, Other: No fulfillment of a preventive programmePatients 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women suffering from axillary lymphadenectomy due to breast cancer in four spanish hospitals
Key inclusion criteria (1 listed)
- Suffering from axillary lymphadenectomy due to breast cancer treatment between 1 january 2014 until 31 december 2016.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Fulfillment of a preventive programmeInformation about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder | Other | No axillary lymphadenectomy sequels, axillary lymphadenectomy sequels |
| No fulfillment of a preventive programmeNo fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder | Other | No axillary lymphadenectomy sequels, axillary lymphadenectomy sequels |
Primary outcome
breast cancer-related lymphedema
Time frame: The agreed date with the participant for the evaluation (second half of 2017)
Truncated cone formula
2 secondary outcomes
functional shoulder limitation
Time frame: The agreed date with the participant for the evaluation (second half of 2017)
Symptoms associated with breast cancer-related lymphedema
Time frame: The agreed date with the participant for the evaluation (second half of 2017)
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 23 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Violeta Pajero Otero, MRes principal investigator
Hospital Universitario 12 de Octubre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Lymphedema and Shoulder Injury, run by Violeta Pajero Otero at 5 sites in Spain.
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 1 inclusion and 3 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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?
breast cancer-related lymphedema (time frame: The agreed date with the participant for the evaluation (second half of 2017)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2018.