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

Phase 2

• Conditions: Diarrhea Caused by Antitumor Drugs
• Interventions: Drug: Traditional Chinese Medicine

• Registration Number: NCT04988165
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-31
• Study First Submitted QC: 2021-07-31
• Study First Posted: 2021-08-03
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-11
• Study Start: 2021-10-08
• Primary Completion: 2022-10-08
• Study Completion: 2022-10-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. Meet the following two conditions:

  2. Planned administration of pyrotinib ≥ 21 days;

  3. 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

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1. Those who may be allergic to pyrotinib or excipients;
2. It has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc;
3. Patients with biliary obstruction;
4. Participate in other diarrhea related clinical trials;
5. 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;
6. 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).
7. Any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Traditional Chinese Medicine	-

Primary Outcome Measures

Name	Time	Method
incidence of grade 3-4 diarrhea	From the beginning of taking traditional Chinese medicine to the 21st day	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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China