N/A
N=670
Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
Breast Cancer Related Lymphedema · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04872738 ↗Enrolled (actual)
670
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: COVID-19 Vaccination on Contralateral vs Ipsilateral Arm — 432; 435; 331; 122 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Survey (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY COVID-19 Vaccination on Contralateral vs Ipsilateral Arm |
432; 435; 331; 122; 119; 74 | — |
| PRIMARY Lymph Node (LN) Swelling After COVID-19 Vaccine |
61; 80; 53; 4; 1; 11 | — |
| PRIMARY Duration of Lymph Node Swelling as a Side Effect of mRNA and Non-mRNA Vaccines |
2; 2; 0; 0; 0; 3 | — |
| PRIMARY Reported Side Effects of the mRNA and Non-mRNA Vaccines |
472; 473; 328; 31; 19; 265 | — |
| PRIMARY Duration of Side Effects of mRNA and Non-mRNA Vaccines |
218; 215; 175; 16; 12; 205 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04872738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.