Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine

Study Overview
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Brief Summary
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Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.

Detailed Description
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Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.

Official Title
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Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine

Conditions
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Diarrhea Caused by Antitumor Drugs

Intervention / Treatment
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* Drug: Traditional Chinese Medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Meet the following two conditions: Planned administration of pyrotinib ≥ 21 days; Grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib; 2. Age ≥ 18 years old; 3. ECOG PS 0-2； 4. Life expectancy ≥ 6 months; 5. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up Exclusion Criteria: Those who may be allergic to pyrotinib or excipients; It has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc; Patients with biliary obstruction; Participate in other diarrhea related clinical trials; Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptives during the whole test period; according to the researchers' judgment, there are serious diseases that endanger the safety of patients, or affect the patients to complete the study (including, but not limited to, severe hypertension and severe diabetes, which can not be controlled by drugs). Any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br> | Drug: Traditional Chinese Medicine<br>* It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of grade 3-4 diarrhea | The number of stools per day increased by ≥ 7 compared with baseline; Incontinence, indication of hospitalization; Compared with baseline, the yield of stoma increased significantly; Daily activities are limited.Life threatening diarrhea | From the beginning of taking traditional Chinese medicine to the 21st day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea, Pyrotinib, Traditional Chinese Medicine