Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment (LymphVAX)

Mass General Brigham

Status: Completed

Conditions: Breast Cancer Related Lymphedema; Covid19

Treatments: Other: Survey

Study type: Observational

Funder types: Other

Identifiers

NCT04872738

21-528

Details and patient eligibility

About

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.

Full 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

Enrollment: 714 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients who are
• ≥18 years of age and have a
• History of breast cancer For the MGH site, patients must have
• Received some breast cancer treatment at MGH or its affiliates
• Received perometry measurements to measure arm volume at MGH

Exclusion criteria

• None

Trial design

714 participants in 2 patient groups

Vaccinated Breast Cancer Patients [mRNA vaccine - Moderna, Pfizer]

Description:

Patients who enroll in the trial and decided to get the COVID-19 vaccine will complete surveys to indicate their experiences, side effects, location of vaccination (i.e. right arm, left arm, or leg). This information will be analyzed in conjunction with their breast cancer treatment history and lymphedema measurements. Participants were separated into two different cohorts for analysis, Cohort 1 being those who received an mRNA vaccine for their primary vaccination series (two doses of Moderna or Pfizer) and Cohort 2 being those who received a non-mRNA vaccination for their primary vaccination series (one dose of Johnson \& Johnson).

Treatment:

Other: Survey

Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson]

Description:

Patients who enroll in the trial and decided to get the COVID-19 vaccine will complete surveys to indicate their experiences, side effects, location of vaccination (i.e. right arm, left arm, or leg). This information will be analyzed in conjunction with their breast cancer treatment history and lymphedema measurements. Participants were separated into two different cohorts for analysis, Cohort 1 being those who received an mRNA vaccine for their primary vaccination series (two doses of Moderna or Pfizer) and Cohort 2 being those who received a non-mRNA vaccination for their primary vaccination series (one dose of Johnson \& Johnson).

Treatment:

Other: Survey