Clinical trial NCT05929001: Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection
Official title: Lymphedema Specific PROs for Risk Assessment, Prevention and Early Detection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lymphedema
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients who are scheduled for or who just had axillary dissection at the University of Miami.

Brief summary: The purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. This potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). It is very important to identify this condition as early as possible to improve the treatment options. This study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old and older with biopsy-proven breast cancer.
* Scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either Jackson Memorial Hospital (JMH) or University of Miami (UM).
* Patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study.
* Intent to continue follow-up for at least 6 months post-operatively.
* Able to give an informed consent to participate in all study's stages.
* Willing and able to fill questionnaires in person or with assistance at baseline and at 6 months from surgery.
* Bilateral axillary dissection patients are eligible to be enrolled for each side.

Exclusion Criteria:

* Previous axillary dissection.
* Lymph node biopsy except for biopsies related to the current cancer event.
* Congenital or acquired arm lymphedema.
* Nephrotic Syndrome
* Anasarca
* Unable or unwilling to fill questionnaires at baseline and at 6 months from surgery.

Primary outcomes:
measure: Change in Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) PRO Scores
timeFrame: Baseline (pre-operative), postoperative, up to 6 months
measure: Change in Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF) PRO Scores
timeFrame: Baseline (pre-operative), postoperative, up to 6 months
measure: Change in Quality of Life Measure for Limb Lymphoedema (LYMQOL) Scores
timeFrame: Baseline (pre-operative), up to 6 months
measure: Change in Lymphedema rate as measured by L-DEX Test
timeFrame: Baseline, Up to 6 months
Secondary outcomes:
measure: Breast Cancer-Related Lymphedema (BCRL) Status: Odds Ratio
timeFrame: Up to 6 months
measure: Breast Cancer-Related Lymphedema (BCRL) Status: Area Under the Receiver Operating Characteristic Curve (AUROC)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Eli Avisar, MD
role: PRINCIPAL_INVESTIGATOR
References: