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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03702868
Enrollment
226
Registered
2018-10-11
Start date
2018-10-10
Completion date
2020-10-30
Last updated
2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant Chemotherapy, Breast Cancer

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.

Interventions

None listed

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
The incidence of chemotherapy related adverse reaction1 yearschemotherapy related adverse reaction are assessed by CTCAE protocol

Secondary

MeasureTime frameDescription
disease free survival5yearsthe length of time after surgery during which no breast cancer is found

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026