## Protocol Section
### Identification Module
**NCT ID:** NCT04138979

**Brief Title:** Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy

**Official Title:** Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy

#### Organization Study ID Info
**ID:** Yunwei Wei 2019-09-13
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2020-10-15

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-10-25

**Type:** ACTUAL

**Last Update Submit Date:** 2019-10-23

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-10-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-09-12

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2019-10-25
**Type:** ACTUAL
**Study First Submit Date:** 2019-10-23
**Study First Submit QC Date:** 2019-10-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** First Affiliated Hospital of Harbin Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Microbiota

**Keywords:**

- gut microbiota

- 16S rRNA gene

- breast cancer chemotherapy

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 20 healthy volunteers were included in the healthy control group

**Label:** Control group

#### Arm Group 2

**Description:** First chemotherapy for breast cancer

**Intervention Names:**

- Drug: cyclophosphamide

**Label:** Disease group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Disease group

**Description:** First use of chemotherapy after breast cancer

**Name:** cyclophosphamide

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The microbiota measured by 16S rRNA gene

**Measure:** Transcriptional changes in gut microbiota

**Time Frame:** baseline,1 day,7 day,14 days,22 days,29 days,36 days,44days,51days,58days,66days,73days,80days

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All patients were included according to the inclusion and exclusion criteria

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hydwyw11@hotmail.com

**Name:** Yunwei Wei, doctor

**Phone:** +86-0451-85553099

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Harbin

**Contacts:**

***Contact 1:***

- **Email:** hydwyw11@hotmail.com

- **Name:** Yunwei Wei

- **Phone:** +86-0451-85553099

- **Role:** CONTACT

**Country:** China

**Facility:** First affiliated hospital of Harbin medical university

**State:** Heilongjiang

**Status:** RECRUITING

**Zip:** 150001

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 28094541

**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, Dore 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.

**PMID:** 20203603

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019653

- Term: Myeloablative Agonists

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6727

- Name: Cyclophosphamide

- Relevance: HIGH

- As Found: Cycle

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003520

- Term: Cyclophosphamide

### Misc Info Module

- Version Holder: 2024-05-24
