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

Terminated

• Conditions: Adjuvant Chemotherapy; Breast Cancer

• Registration Number: NCT03702868
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-02
• Study Start: 2018-10-10
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-11
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 226

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of chemotherapy related adverse reaction	1 years	chemotherapy related adverse reaction are assessed by CTCAE protocol

Secondary Outcome Measures

Name	Time	Method
disease free survival	5years	the length of time after surgery during which no breast cancer is found

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China