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

NCT ID: NCT03702868

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-10

Study Completion Date

2020-10-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Adjuvant Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhong-yu Yuan

Professor Zhongyu Yuan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhong-yu Yuan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSUCC-011

Identifier Type: -

Identifier Source: org_study_id

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