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Clinical Trial Summary

This study aims to elicit patient experiences, choices, and side effects associated with the COVID-19 vaccine after breast cancer surgery. Lymph node swelling is a known and common side effect of both the Moderna and Pfizer COVID-19 vaccines. This is the body's normal reaction to the vaccine. It is worrisome that lymph node swelling after the vaccine mimics that found in breast cancer which has spread to the lymph nodes. This side effect will cause worry and anxiety amongst patients as a result. For patients who have had lymph node removal (axillary lymph node dissection or sentinel lymph node biopsy) and are at risk of lymphedema, the investigators are concerned that the lymph node swelling may tax the lymphatic system and incite lymphedema in those at risk or worsen it in those with BCRL. Fear of lymphedema is high in this population and the investigators need to better understand what risk, if any, lymph node swelling after the COVID-19 vaccine imparts to BCRL risk.


Clinical Trial Description

- Hypothesis 1: Patients will choose to receive the vaccine on the arm contralateral to axillary lymph node removal, or in the lower extremity if they have had bilateral axillary lymph node removal - Hypothesis 2: Patients with a history of breast cancer will experience axillary lymph node swelling after receiving the COVID-19 vaccine at the same rate as the general population - Hypothesis 3: Patients with axillary surgery who develop lymph nodes swelling in the ipsilateral side might be at increased risk of developing lymphedema ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04872738
Study type Observational
Source Massachusetts General Hospital
Contact
Status Active, not recruiting
Phase
Start date May 7, 2021
Completion date December 1, 2024

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