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Prevention and treatment of pyrotinib-associated diarrhea: a prospective, multicenter, randomized, open-label controlled clinical study

Prevention and treatment of pyrotinib-associated diarrhea: a prospective, multicenter, randomized, open-label controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032236
Enrollment
Unknown
Registered
2020-04-23
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

Breast cancer

Interventions

Non-secondary prevention group:Loperamide
secondary prevention group(A):Loperamide
secondary prevention group(B):Loperamide and Live Combined Bifidobacterium
secondary prevention group (C):Loperamide and Montmorillonite powder
secondary prevention group (D):Non-prevention

Sponsors

Tianjin Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. One of the following two conditions: (1) Patients who plan to take pyrrolidine >= 21 days; (2) At present, patients with grade 3 diarrhea or grade 3 diarrhea accompanied with complications after taking pyrrolidine plan to take pyrrolidine >= 21 days; 2. Patients over 18 years old; 3. Patients with ECoG PS 0-2; 4. Patients with life expectancy >= 6 months; 5. Volunteer to join the study, sign informed consent, have good compliance and be willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who may be allergic to pyrrolidine or excipients; 2. Patients with multiple factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc.; 3. Patients with biliary obstruction; 4. Patients participating in other diarrhea related clinical trials; 5. 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 test period; 6. According to the judgment of the researcher, patients with serious hazards to the safety of patients, or accompanying diseases that affect the completion of the study (including but not limited to severe hypertension, severe diabetes, etc., which cannot be controlled by drugs); 7. Any other circumstances in which the patient is not considered suitable for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Stool frequency;

Countries

China

Contacts

Public ContactHong Liu

Tianjin Cancer Hospital

hrkangruijun@163.com+86 18622221169

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026