Impact of Chemoradiation on Pneumococcal Vaccine Response in Esophageal Cancer Patients
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
This study is testing how radiation treatment affects the immune response to a pneumonia vaccine in patients with esophageal cancer who have low white blood cell counts after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06181656 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how radiation treatment affects the immune response to pneumococcal vaccination in patients with esophageal cancer who experience high-grade lymphopenia after chemoradiation. The primary objective is to determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to the vaccine. Secondary objectives include evaluating the effects of different radiation modalities on vaccine response, systemic immunity, and the incidence of pneumonia among vaccinated patients. The study will also explore the relationship between immune changes and clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates include esophageal cancer patients undergoing or recently completed chemoradiation, as well as healthy individuals for comparison.
Not a fit: Patients with compromised immune systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies for esophageal cancer patients, potentially reducing pneumonia incidence.
How similar studies have performed: Other studies have shown varying impacts of radiation on immune responses, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Group 1A a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons. 2. Group 1B a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT) 3. Group 2A a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma. 4. Group 2B a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma. 5. Group 3 a. Healthy age- and gender- matched individuals 6. All Groups 1. Patients of all genders, races and nationalities will be solicited. 2. Age \>18 years 3. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment. * Patients with psychiatric illness/social situations that would limit compliance with study requirements. * Individuals with previous pneumococcal vaccination in the last 5 years. * Individuals with severe allergy to any of the vaccine components
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Steven H Lin, MD — M.D. Anderson Cancer Center
- Study coordinator: Steven H Lin, MD
- Email: shlin@mdanderson.org
- Phone: (713) 563-8490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.