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, we 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 we need to better understand what risk, if any, lymph node swelling after the COVID-19 vaccine imparts to BCRL risk.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: December 31, 2021
– 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
- 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.
Arms, Groups and Cohorts
- 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.
- 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.
Clinical Trial Outcome Measures
- COVID-19 Vaccination
- Time Frame: 1 week to 6 months
- Participation in the study will be complete once a participant has gotten vaccinated and all side effects have resolved or six weeks after the date of their second vaccination, whichever comes first.
- Decision not to receive COVID-19 Vaccine
- Time Frame: 1 month
- Participation for those who will not get the COVID-19 vaccine will be complete once they complete a survey explaining their decision. We are looking to see if this decision was related to their history of breast cancer or breast cancer-related lymphedema, or being at-risk of developing breast cancer-related lymphedema.
Participating in This Clinical Trial
- 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:
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Massachusetts General Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Alphonse Taghian, MD, PhD, Director, Lymphedema Research Program – Massachusetts General Hospital
- Overall Official(s)
- Alphonse G Taghian, MD, PhD, Principal Investigator, Massachusetts General Hospital
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