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

NCT04872738 | Completed Results

• 1 other identifier: 21-528
• Study Type: observational
• Target: 714
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Related Lymphedema; Covid19

Keywords

Breast Cancer; Vaccination; Lymphadenopathy

Outcome Measures

Primary Outcomes (5)

• COVID-19 Vaccination on Contralateral vs Ipsilateral Arm

  The investigators expect 90% of participants to receive the COVID-19 vaccine on their contralateral (unaffected) arm. This outcome measure is looking at the number of participants who received the COVID-19 vaccine on the side of breast cancer treatment vs those who received the vaccine on the opposite side of breast cancer treatment. Patients with bilateral cancer were excluded from this analysis due to the nature of breast cancer laterality categorization.

  This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.

• Lymph Node (LN) Swelling After COVID-19 Vaccine

  The investigators expect 10-15% of participants to experience lymph node swelling after receiving the Pfizer or Moderna vaccines. The outcome measure analyzes the number of participants who experienced LN swelling after receiving each dose of their COVID-19 vaccines. The analysis looked at what location on the body lymph node swelling occurred (axilla vs supraclavicular region), which side of the body this swelling occurred in relation to the side of the body that received the vaccine (ipsilateral vs contralateral), and which side of the body this swelling occurred in relation to the side of the body the patient has/had breast cancer (ipsilateral vs contralateral). Patients with bilateral cancer were excluded from the analysis of LN swelling in relation to both the vaccine and breast cancer laterality due to the nature of BC laterality categorization. Analysis on breast cancer laterality and LN swelling was not conducted for the non-mRNA vaccine (Johnson \& Johnson) group.

  This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.

• Duration of Lymph Node Swelling as a Side Effect of mRNA and Non-mRNA Vaccines

  The outcome measure will be analyzing the reported duration of lymph node swelling, categorized by the location at which lymph node swelling occurred (the axilla vs supraclavicular region) and which side of the body this swelling occurred in relation to the side of the body that received the vaccine injection (ipsilateral vs contralateral). The main aim of this paper was to report the side effects of the mRNA COVID-19 vaccines in patients treated for breast cancer.

  This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.

• Reported Side Effects of the mRNA and Non-mRNA Vaccines

  Due to the inherent activity of mRNA vaccines and the immune system, as well as the role of the lymph nodes in breast cancer (BC) and in breast cancer-related lymphedema (BCRL), this study analyzed the side effect profile in patients treated for BC and who received up to three doses of the COVID-19 vaccinations \[Moderna, Pfizer\]. A separate analysis is presented on results from participants who received the Johnson \& Johnson (J\&J) vaccine as lymph node swelling is not a listed side effect of this non-mRNA vaccine and only a small proportion of the population received this vaccine.

  This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.

• Duration of Side Effects of mRNA and Non-mRNA Vaccines

  Due to the inherent activity of mRNA vaccines and the immune system, as well as the role of the lymph nodes in breast cancer (BC) and in breast cancer-related lymphedema (BCRL), this study analyzed the side effect profile in patients treated for BC and who received up to three doses of the COVID-19 vaccinations \[Moderna, Pfizer\]. A separate analysis is presented on results from participants who received the Johnson \& Johnson (J\&J) vaccine as lymph node swelling is not a listed side effect of this non-mRNA vaccine and only a small proportion of the population received this vaccine. This outcome analyzes the duration of side effects associated with each dose of the vaccine.

  This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.

Study Arms (2)

Vaccinated Breast Cancer Patients [mRNA vaccine - Moderna, Pfizer]

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).

Other: Survey

Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson]

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).

Other: Survey

Interventions

Survey OTHER

Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced.

Vaccinated Breast Cancer Patients [mRNA vaccine - Moderna, Pfizer]; Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson]

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with a history of breast cancer

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Juhel 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 DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema; COVID-19; Breast Neoplasms; Lymphadenopathy

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

It is difficult to determine the exact response rate as surveys were sent when many patients hadn't yet received the vaccine; recall bias may have played a role. Questions regarding LN swelling relied on self-report. The surveys do not include questions regarding the severity of the side effects reported; therefore, conclusions about severity cannot be drawn. Methodological limitations prevent statistical comparisons with studies of the general population.

Results Point of Contact

• Title: Associate Director, Lymphedema Research Program
• Organization: Massachusetts General Hospital

cbrunelle@mgh.harvard.edu

617-724-0127

Study Officials

• Alphonse G Taghian, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lymphedema Research Program

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 4, 2021
• Study Start: May 7, 2021
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)