Clinical trial · Observational
Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Related Lymphedema | — | UNRESOLVED | — |
| Covid19 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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).
- interventionNames
- Other: Survey
- label
- 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).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJuhel BC, Brunelle CL, Bernstein MC, Smith LH, Jung AW, Ababneh HS, Hausman EK, Bucci LK, Bernstein T, Naoum GE, Taghian AG. Side effects of COVID-19 vaccinations in patients treated for breast cancer. Clin Exp Med. 2023 Nov;23(7):3671-3680. doi: 10.1007/s10238-023-01050-z. Epub 2023 Apr 8. PMID 37031282