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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Vaccinated Breast Cancer Patients 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.
  • Other: Survey
    Patients in all groups will complete surveys about their decision to receive or not to receive the COVID-19 vaccine. For those who did receive the vaccine, they will indicate their experience with the vaccination and any side effects they may have experienced.
Unvaccinated Breast Cancer Patients Patients who enroll in the trial and did not choose to receive the COVID-19 vaccine once it was available to them with complete a survey to indicate why they chose not to receive the vaccine. This information will be analyzed in conjunction with their breast cancer treatment history and lymphedema measurements.
  • Other: Survey
    Patients in all groups will complete surveys about their decision to receive or not to receive the COVID-19 vaccine. For those who did receive the vaccine, they will indicate their experience with the vaccination and any side effects they may have experienced.

Recruiting Locations

More Details

NCT ID
NCT04872738
Status
Completed
Sponsor
Massachusetts General Hospital

Detailed 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.