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Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer

Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer

Recruiting
18 years and older
All
Phase N/A

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Overview

To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured by cytokine expression (IFN gamma)

Eligibility

Inclusion Criteria:

  • Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a biopsy-proven NSCLC
  • Age 18 years old or older
  • Patient capable of giving informed consent

Exclusion Criteria:

  • Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
  • Active infection with oral temperature >100°F
  • Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
  • Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
  • Documented history of HIV, HBV or HCV
  • Chronic constipation (bowel movements less frequent than every other day)
  • Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (within 2 years of lung cancer diagnosis) or Helicobacter Pylori infection (untreated)
  • Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
  • Patients on anti-diarrheal medications
  • Patients on probiotics

Study details
    Early Stage Non-Small Cell Lung Cancer

NCT03546829

Abramson Cancer Center at Penn Medicine

27 January 2024

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