Patient Experiences with the COVID-19 Vaccination After Breast Cancer Treatment
(LymphVAX Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlphonse G Taghian, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alphonse G Taghian, MD, PhD

Principal Investigator

Massachusetts General Hospital

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

See 2 more

Treatment Details

Interventions

COVID-19 Vaccine Patient Experience Survey (Survey)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Vaccinated Breast Cancer PatientsExperimental Treatment1 Intervention

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.

Group II: Unvaccinated Breast Cancer PatientsExperimental Treatment1 Intervention

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.