Clinical trial NCT04987424: Prevalence of Lymphedema in Valle Del Cauca, Colombia.
Official title: Prevalence Of Upper Limb Lymphedema In Patients Diagnosed With Breast Cancer In A Valle Del Cauca Oncology Institution In A 2008-2020 Cohort In Colombia.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unilateral Breast Cancer
Keywords: Lymphedema
breast cancer
prevalence
risk factors
epidemiology
Lead sponsor: Grupo de investigación C.E.R
Sponsor class: OTHER
Collaborators: name: Hematooncologos S.A.
First posted: 2021-08-03
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between 2008 and 2020 a sample of 367 patients with a diagnosis of unilateral breast cancer was established

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of lymphedema
timeFrame: 2014-2020
Secondary outcomes:
measure: Risk Factors
timeFrame: 2014-2020
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Hematoncologos S.A
state: Valle Del Cauca
Study officials:
References:
citation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.