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Completed

NCT Number: NCT04872738

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

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.

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Key information

Conditions

Breast Cancer Related Lymphedema Breast Cancer Lymphedema Breast Diseases Breast Neoplasms COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Hemic and Lymphatic Diseases Infections Lung Diseases Lymphadenopathy Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Postoperative Complications RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

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

Primary outcomes

  1. COVID-19 Vaccination on Contralateral vs Ipsilateral Arm

    Time frame: 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.

    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.

  2. Lymph Node (LN) Swelling After COVID-19 Vaccine

    Time frame: 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.

    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.

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

    Time frame: 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.

    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.

  4. Reported Side Effects of the mRNA and Non-mRNA Vaccines

    Time frame: 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.

    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.

  5. Duration of Side Effects of mRNA and Non-mRNA Vaccines

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: LymphVAX

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 4, 2021
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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