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

Breast Cancer Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300349
• Other study ID #: InveCuidRh001
• Status: Completed
• Phase: N/A
• First received: September 28, 2017
• Last updated: February 22, 2018
• Start date: September 27, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Shoulder Injuries
• Shoulder Injury

Intervention

Other:
• Fulfillment of a preventive programme
Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
• No 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

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Cartagena	Cartagena	Murcia
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Castilla-La Mancha University	Toledo

Sponsors (5)

Lead Sponsor	Collaborator
Violeta Pajero Otero	Complejo Hospitalario Universitario de Cartagena, Hospital Universitario 12 de Octubre, Puerta de Hierro University Hospital, University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree of compliance with the prevention program	questionnaire	The agreed date with the participant for the evaluation (second half of 2017)
Primary	breast cancer-related lymphedema	Truncated cone formula	The agreed date with the participant for the evaluation (second half of 2017)
Secondary	functional shoulder limitation	Shoulder Pain and Disability Index	The agreed date with the participant for the evaluation (second half of 2017)
Secondary	Symptoms associated with breast cancer-related lymphedema	Visual Analogic Scale	The agreed date with the participant for the evaluation (second half of 2017)