Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prospective Cohort Study of Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03702868
• Other study ID #: SYSUCC-011
• Status: Terminated
• Start date: October 10, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.

The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Description:

Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.

The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event.

We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 226
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically diagnosed stage I-III breast cancer;

• Plan to receive adjuvant chemotherapy in our hospital;

• Sign the informed consent;

• Good compliance and willing to follow up.

Exclusion Criteria:

• Those who have started receiving adjuvant chemotherapy;

• Chemotherapy contraindications;

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of chemotherapy related adverse reaction	chemotherapy related adverse reaction are assessed by CTCAE protocol	1 years
Secondary	disease free survival	the length of time after surgery during which no breast cancer is found	5years