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

Covid19 Clinical Trial

— LymphVAX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04872738
• Other study ID #: 21-528
• Status: Active, not recruiting
• Start date: May 7, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• COVID-19
• Covid19
• Lymphedema

Intervention

Other:
• Survey
Patients in all groups will complete surveys about their decision to receive or not to receive the COVID-19 vaccine. For those who did receive the vaccine, they will indicate their experience with the vaccination and any side effects they may have experienced.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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