Gut Microbiota And Radiotherapy
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2015 |
Contact: | Edgar Ben-Josef, MD |
Email: | PennCancerTrials@emergingmed.com |
Phone: | 855-216-0098 |
A pilot, single arm, single center study to determine the feasibility of obtaining stool
samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the
gut microbiota and to obtain preliminary data about possible correlation of baseline
composition and changes in gut microbiota with tumor response, local control, and
development of pneumonitis/other side effects.
samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the
gut microbiota and to obtain preliminary data about possible correlation of baseline
composition and changes in gut microbiota with tumor response, local control, and
development of pneumonitis/other side effects.
Inclusion Criteria:
- Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion
(either presumed or 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).
- Confirmed or suspected 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 (recurrent) 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
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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