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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    40
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 4 March 2022

Summary

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

Details
Condition Early Stage Non-Small Cell Lung Cancer
Treatment Stereotactic Body Radiation Therapy (SBRT), Vancomycin
Clinical Study IdentifierNCT03546829
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

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
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