We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04872738
Recruitment Status : Active, not recruiting
First Posted : May 4, 2021
Last Update Posted : March 31, 2023
Sponsor:
Information provided by (Responsible Party):
Alphonse Taghian, Massachusetts General Hospital

Tracking Information
First Submitted Date May 2, 2021
First Posted Date May 4, 2021
Last Update Posted Date March 31, 2023
Actual Study Start Date May 7, 2021
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2021)
  • COVID-19 Vaccination on Contralateral Arm [ Time Frame: 0 to 6 months ]
    The investigators expect 90% of participants to receive the COVID-19 vaccine on their contralateral (unaffected) arm.
  • Lymph Node Swelling after mRNA COVID-19 Vaccine [ Time Frame: 0 to 3 months ]
    The investigators expect 10-15% of participants to experience lymph node swelling after receiving the Pfizer or Moderna vaccines.
Original Primary Outcome Measures
 (submitted: May 2, 2021)		 COVID-19 Vaccination [ Time Frame: 1 week to 6 months ]
Participation in the study will be complete once a participant has gotten vaccinated and all side effects have resolved or six weeks after the date of their second vaccination, whichever comes first.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 2, 2021)		 Decision not to receive COVID-19 Vaccine [ Time Frame: 1 month ]
Participation for those who will not get the COVID-19 vaccine will be complete once they complete a survey explaining their decision. We are looking to see if this decision was related to their history of breast cancer or breast cancer-related lymphedema, or being at-risk of developing breast cancer-related lymphedema.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
Official Title Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with a history of breast cancer
Condition
  • Breast Cancer Related Lymphedema
  • Covid19
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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: Survey
  • 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.
    Intervention: Other: Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 30, 2023)		 670
Original Estimated Enrollment
 (submitted: May 2, 2021)		 2000
Estimated Study Completion Date December 1, 2023
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
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
  • Received some breast cancer treatment at MGH or its affiliates
  • Received perometry measurements to measure arm volume at MGH

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04872738
Other Study ID Numbers 21-528
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Alphonse Taghian, Massachusetts General Hospital
Original Responsible Party Alphonse Taghian, MD, PhD, Massachusetts General Hospital, Director, Lymphedema Research Program
Current Study Sponsor Massachusetts General Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Alphonse G Taghian, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2023