Patient Experiences with the COVID-19 Vaccination After Breast Cancer Treatment

Completed

• Conditions: Breast Cancer Related Lymphedema; Covid19
• Interventions: Other: Survey

• Registration Number: NCT04872738
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

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

Study Timeline

• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-02
• Study First Posted: 2021-05-04
• Study Start: 2021-05-07
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 670

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unvaccinated Breast Cancer Patients	Survey	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.
Vaccinated Breast Cancer Patients	Survey	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.

Primary Outcome Measures

Name	Time	Method
Lymph Node Swelling after mRNA COVID-19 Vaccine	0 to 3 months	The investigators expect 10-15% of participants to experience lymph node swelling after receiving the Pfizer or Moderna vaccines.
COVID-19 Vaccination on Contralateral Arm	0 to 6 months	The investigators expect 90% of participants to receive the COVID-19 vaccine on their contralateral (unaffected) arm.

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States