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Completed

NCT Number: NCT03300349

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

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.

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Key information

Conditions

Breast Cancer Lymphedema Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Injuries Shoulder Injury Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fulfillment of a preventive programme

Other

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

No fulfillment of a preventive programme

Other

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

Primary outcomes

  1. breast cancer-related lymphedema

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

    Truncated cone formula

Secondary outcomes

  1. functional shoulder limitation

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

    Shoulder Pain and Disability Index

  2. Symptoms associated with breast cancer-related lymphedema

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

    Visual Analogic Scale

Other outcomes

  1. Degree of compliance with the prevention program

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

    questionnaire

Sponsors and collaborators

Lead sponsor

Violeta Pajero Otero

Other

Collaborators

  • Complejo Hospitalario Universitario de Cartagena
  • Hospital Universitario 12 de Octubre
  • Puerta de Hierro University Hospital
  • University of Castilla-La Mancha

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2017
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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