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Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Take probiotics
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Plan to take pyrrolidine or naratinib for ≥ 28 days; HER2 positive female patients with breast cancer aged ≥ 18 years and ≤ 65 years; Patients with the following treatment schemes: 1. Pirotinib/naratinib monotherapy 2. Pirotinib/naratinib combined endocrine therapy; 4. The ECOG score is 0-1; Life expectancy ≥ 6 months; Patients who followed diet intervention after enrollment; Volunteer to join the study, sign the informed consent form, have good compliance and are willing to cooperate with follow-up. Exclusion Criteria: People who may be allergic to pyrrolidine, naratinib or excipients; There are many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting; Patients with biliary obstruction; Participate in other clinical trials related to diarrhea; Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period; According to the judgment of the investigator, there are concomitant diseases (including but not limited to severe hypertension and severe diabetes beyond drug control) that seriously endanger the patient's safety or affect the patient's completion of the study; Have taken other drugs that may cause diarrhea adverse reactions within 3 weeks before enrollment; There are drugs with high probability of causing diarrhea adverse reactions in patients' combined medication; Any other situation in which the researcher believes that the patient is not suitable to participate in this study.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diarrhea group

No diarrhea group

Arm Description

Patients with diarrhea after taking pyrrolidine/naratinib,implement intervention (Yihuo 0.2g po bid+ Gold bifidum 2g po tid)

Patients without diarrhea after taking pyrrolidine/naratinib

Outcomes

Primary Outcome Measures

Diarrhea grading
Score according to the diarrhea grading:grading score: 0(None);1(Increased bowel movements < 4 times per day compared to before treatment); 2(Increased bowel movements 4 to 6 times/day or night compared to before treatment);3( Increased number of stools ≥ 7 times/day compared with before treatment, fecal incontinence, severe abdominal pain or fecal incontinence, affecting daily activities and requiring hospitalization); 4(life-threatening (e.g. circulatory failure));5(Death).

Secondary Outcome Measures

Time of the first occurrence of diarrhea
The median time of the first occurrence of diarrhea
Duration of diarrhea
The median duration of diarrhea
Time of the first occurrence of grade 3 diarrhea
The median time of the first occurrence of grade 3 diarrhea
Duration of grade 3 diarrhea
The median duration of grade 3 diarrhea
Adverse events
Occurrence of other adverse events

Full Information

First Posted
March 6, 2023
Last Updated
April 11, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05773391
Brief Title
Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure)
Official Title
A Prospective Phase II Study About Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model in HER2+ Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Small-molecule tyrosine kinase inhibitors (TKI) that target HER2 are routinely used to treat patients with HER2 (+) breast cancer. The main adverse reactions included diarrhea, nausea, and rash, among which diarrhea had the highest incidence. It can reduce the quality of life and medication compliance of patients, and further affect the efficacy of TKI anti-tumor therapy. Therefore, the investigators conducted this study to establish a risk assessment model before TKI treatment, in order to screen out the high-risk population and influencing factors of TKI-associated diarrhea, and planned to carry out corresponding animal experiments to verify the relationship between various mechanisms and the main mechanism in TKI-associated diarrhea and to explore the corresponding treatment methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diarrhea group
Arm Type
Experimental
Arm Description
Patients with diarrhea after taking pyrrolidine/naratinib,implement intervention (Yihuo 0.2g po bid+ Gold bifidum 2g po tid)
Arm Title
No diarrhea group
Arm Type
No Intervention
Arm Description
Patients without diarrhea after taking pyrrolidine/naratinib
Intervention Type
Drug
Intervention Name(s)
Take probiotics
Intervention Description
Take medication for 21 days (Yihuo 0.2g bid+ Jin Bifid2g tid)
Primary Outcome Measure Information:
Title
Diarrhea grading
Description
Score according to the diarrhea grading:grading score: 0(None);1(Increased bowel movements < 4 times per day compared to before treatment); 2(Increased bowel movements 4 to 6 times/day or night compared to before treatment);3( Increased number of stools ≥ 7 times/day compared with before treatment, fecal incontinence, severe abdominal pain or fecal incontinence, affecting daily activities and requiring hospitalization); 4(life-threatening (e.g. circulatory failure));5(Death).
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Time of the first occurrence of diarrhea
Description
The median time of the first occurrence of diarrhea
Time Frame
28 days
Title
Duration of diarrhea
Description
The median duration of diarrhea
Time Frame
28 days
Title
Time of the first occurrence of grade 3 diarrhea
Description
The median time of the first occurrence of grade 3 diarrhea
Time Frame
28 days
Title
Duration of grade 3 diarrhea
Description
The median duration of grade 3 diarrhea
Time Frame
28 days
Title
Adverse events
Description
Occurrence of other adverse events
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Plan to take pyrrolidine or naratinib for ≥ 28 days; HER2 positive female patients with breast cancer aged ≥ 18 years and ≤ 65 years; Patients with the following treatment schemes: 1. Pirotinib/naratinib monotherapy 2. Pirotinib/naratinib combined endocrine therapy; 4. The ECOG score is 0-1; Life expectancy ≥ 6 months; Patients who followed diet intervention after enrollment; Volunteer to join the study, sign the informed consent form, have good compliance and are willing to cooperate with follow-up. Exclusion Criteria: People who may be allergic to pyrrolidine, naratinib or excipients; There are many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting; Patients with biliary obstruction; Participate in other clinical trials related to diarrhea; Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period; According to the judgment of the investigator, there are concomitant diseases (including but not limited to severe hypertension and severe diabetes beyond drug control) that seriously endanger the patient's safety or affect the patient's completion of the study; Have taken other drugs that may cause diarrhea adverse reactions within 3 weeks before enrollment; There are drugs with high probability of causing diarrhea adverse reactions in patients' combined medication; Any other situation in which the researcher believes that the patient is not suitable to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Fei, MD
Phone
+86-13711277870
Email
xufei@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Kuikui, MD
Phone
+86-15210589011
Email
jiangkk@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Xu, MD
Phone
+86-13711277870
Email
xufei@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Fei Xu, MD

12. IPD Sharing Statement

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Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure)

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