Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Stage IB Lung Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Stage IA1 Lung Cancer AJCC v8
- Stage I Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IA3 Lung Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Stage IA2 Lung Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Breast Adenocarcinoma
- Prognostic Stage IA Breast Cancer AJCC v8
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To conduct a pilot study of probiotics prior to surgery in operable breast and lung cancer patients. II. To evaluate systemic and intratumoral immunomodulatory effects of probiotics in operable breast and lung cancer patients. OUTLINE: Patients undergo collection of blood samp...
PRIMARY OBJECTIVES: I. To conduct a pilot study of probiotics prior to surgery in operable breast and lung cancer patients. II. To evaluate systemic and intratumoral immunomodulatory effects of probiotics in operable breast and lung cancer patients. OUTLINE: Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics orally (PO) once on day 1, and then twice daily (BID) or three times daily (TID) for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
Tracking Information
- NCT #
- NCT04857697
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Saranya Chumsri Mayo Clinic
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