Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy

Microbiota Clinical Trial

Official title:

Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04138979
• Other study ID #: Yunwei Wei 2019-09-13
• Status: Recruiting
• Start date: September 12, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: September 2019
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yunwei Wei, doctor
• Phone: +86-0451-85553099
• Email: hydwyw11[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.

Description:

To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.At present, studies on the interaction mechanism between intestinal flora and breast cancer mainly focus on two aspects: first, intestinal flora affects the occurrence and progress of breast cancer by affecting estrogen metabolism;Second, intestinal flora can influence the occurrence and treatment of breast cancer by affecting the regulation of the immune system.However, the specific types (or groups) of bacteria that promote the occurrence, development and mechanism of breast cancer still need to be further studied.In addition, since most of the current clinical studies on microorganisms and breast cancer are small sample studies, the accuracy of their conclusions remains to be studied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 65 years

• First use of chemotherapy after breast cancer

Exclusion Criteria:

• Pregnancy

• Lactation

• Cigarette smoking

• Alcohol addiction

• Hypertension

• Diabetes mellitus

• Lipid dysregulation

• BMI > 27

• Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine

• History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD

• History of malignancy or any gastrointestinal tract surgery

Related Conditions & MeSH terms

• Breast Neoplasms
• Microbiota

Intervention

Drug:
• cyclophosphamide
First use of chemotherapy after breast cancer

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Luu TH, Michel C, Bard JM, Dravet F, Nazih H, Bobin-Dubigeon C. Intestinal Proportion of Blautia sp. is Associated with Clinical Stage and Histoprognostic Grade in Patients with Early-Stage Breast Cancer. Nutr Cancer. 2017 Feb-Mar;69(2):267-275. doi: 10.1080/01635581.2017.1263750. Epub 2017 Jan 17. — View Citation

Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Doré J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium, Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptional changes in gut microbiota	The microbiota measured by 16S rRNA gene	baseline,1 day,7 day,14 days,22 days,29 days,36 days,44days,51days,58days,66days,73days,80days