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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04872738
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 24.8
• Patients Per Site Per Month: 80.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Related Lymphedema; Covid19	Other: Survey

Detailed 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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
• Actual Study Start Date: May 7, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Vaccinated Breast Cancer Patients 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.	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.
Unvaccinated Breast Cancer Patients 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.	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.

Outcome Measures

Primary Outcome Measures

1. COVID-19 Vaccination on Contralateral Arm [0 to 6 months]

   The investigators expect 90% of participants to receive the COVID-19 vaccine on their contralateral (unaffected) arm.

2. Lymph Node Swelling after mRNA COVID-19 Vaccine [0 to 3 months]

   The investigators expect 10-15% of participants to experience lymph node swelling after receiving the Pfizer or Moderna vaccines.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Alphonse G Taghian, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alphonse Taghian, MD, PhD, Director, Lymphedema Research Program, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04872738
• Other Study ID Numbers: 21-528
• First Posted: May 4, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alphonse Taghian, MD, PhD, Director, Lymphedema Research Program, Massachusetts General Hospital: Breast Cancer; Vaccination; Lymphadenopathy
• Additional relevant MeSH terms: COVID-19; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema

Study Results

No Results Posted as of Apr 6, 2022