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

NCT05773391 | Unknown

• 1 other identifier: SYSU-2022-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time of the first occurrence of diarrhea

  28 days

• Duration of diarrhea

  28 days

• Time of the first occurrence of grade 3 diarrhea

  28 days

• Duration of grade 3 diarrhea

  28 days

• Adverse events

  28 days

Study Arms (2)

Diarrhea group

EXPERIMENTAL

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

Drug: Take probiotics

No diarrhea group

NO INTERVENTION

Patients without diarrhea after taking pyrrolidine/naratinib

Interventions

Take probiotics DRUG

Take medication for 21 days (Yihuo 0.2g bid+ Jin Bifid2g tid)

Diarrhea group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xu Fei, MD

CONTACT

+86-13711277870; xufei@sysucc.org.cn

Jiang Kuikui, MD

CONTACT

+86-15210589011; jiangkk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: April 12, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)