Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/7/2018 |
Start Date: | April 24, 2018 |
End Date: | December 24, 2020 |
Contact: | Abigail Berman, MD |
Email: | PennCancerTrials@emergingmed.com |
Phone: | 855-216-0098 |
To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured
by cytokine expression (IFN gamma)
by cytokine expression (IFN gamma)
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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Abigail Berman, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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