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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773391
• Other study ID #: SYSU-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Xu Fei, MD
• Phone: +86-13711277870
• Email: xufei[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Diarrhea

Intervention

Drug:
• Take probiotics
Take medication for 21 days (Yihuo 0.2g bid+ Jin Bifid2g tid)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	28 days
Secondary	Time of the first occurrence of diarrhea	The median time of the first occurrence of diarrhea	28 days
Secondary	Duration of diarrhea	The median duration of diarrhea	28 days
Secondary	Time of the first occurrence of grade 3 diarrhea	The median time of the first occurrence of grade 3 diarrhea	28 days
Secondary	Duration of grade 3 diarrhea	The median duration of grade 3 diarrhea	28 days
Secondary	Adverse events	Occurrence of other adverse events	28 days