Spots Global Cancer Trial Database for Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer

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Trial Identification

Brief Title: Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer

Official Title: Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer

Study ID: NCT04857697

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Breast Adenocarcinoma

Stage I Lung Cancer AJCC v8

Stage II Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Interventions

Biopsy

Biospecimen Collection

Probiotic

Therapeutic Conventional Surgery

Study Description

Brief Summary: This clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body's immune system to react to stage I-III breast or lung cancers that can be removed by surgery (operable). Having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. Taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.

Detailed 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 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.