Covid19 Clinical Trial
— LymphVAXOfficial title:
Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
Verified date | December 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 670 |
Est. completion date | December 1, 2024 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | COVID-19 Vaccination on Contralateral Arm | The investigators expect 90% of participants to receive the COVID-19 vaccine on their contralateral (unaffected) arm. | 0 to 6 months | |
Primary | Lymph Node Swelling after mRNA COVID-19 Vaccine | The investigators expect 10-15% of participants to experience lymph node swelling after receiving the Pfizer or Moderna vaccines. | 0 to 3 months |
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