Prevalence of Lymphedema in Valle Del Cauca, Colombia.

• Conditions: Unilateral Breast Cancer

• Registration Number: NCT04987424
• Lead Sponsor: Grupo de investigación C.E.R

Brief Summary

This is an epidemiological cross-sectional study aiming to determine the prevalence of lymphedema and the incidence of risk factors in patients diagnosed with unilateral breast cancer in a cohort from 2008 to 2020 in a specialised oncology centre in Valle del Cauca, Colombia.

Detailed Description

CONTEXT: Breast cancer-associated lymphedema is considered one of the most frequent side effects of breast cancer therapy. (1,2) Despite the abundant information available worldwide on epidemiology and risk factors, little is known about these data in Colombia and Latin America.

OBJECTIVE: To determine the actual prevalence and incidence of risk factors for the development of lymphedema associated with breast cancer in a specialised oncology centre in Valle del Cauca, Colombia.

DESIGN, SETTING, AND PATIENTS: Between 2008 and 2020 a sample of 367 patients with a diagnosis of unilateral breast cancer was established, with which a descriptive study was carried out, in which a series of anthropometric measurements were taken of the upper limbs in order to obtain the volume of both arms and determine the prevalence of lymphedema using the formula of truncated volumes of the Spanish society of lymphology, after which the medical records were reviewed in order to collect other data of interest. Patients were excluded if they had bilateral breast cancer or direct trauma to the upper limb.

INTERVENTIONS: A single intervention was carried out in which the patients were summoned for an interview and anthropometric measurements of the upper limbs, thus calculating the arm volume for a lymphedema primary diagnosis .

Study Timeline

• Study Start: 2018-01-18
• Primary Completion: 2020-12-31
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-23
• Status Verified: 2021-08
• Study First Posted: 2021-08-03
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-09
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 367

Inclusion Criteria

• Unilateral breast cancer, cancer diagnosis between 2008-2020 in the oncology institution Colombia

Exclusion Criteria

• Moving to a different institution for attention (other than Hemato-Oncólogos SA), unwillingness to become volunteer and death, bilateral breast cancer, congenital disease or trauma in the upper limb.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of lymphedema	2014-2020	Determining the prevalence of lymphedema in patients diagnosed with unilateral breast cancer

Secondary Outcome Measures

Name	Time	Method
Risk Factors	2014-2020	Determining risk factors for the development of lymphedema in patients diagnosed with unilateral breast cancer

Trial Locations

Locations (1)

Hematoncologos S.A; 🇨🇴 Cali, Valle Del Cauca, Colombia