UnknownPhase 2

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

China30 participantsStarted 2021-10-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Planned administration of pyrotinib ≥ 21 days;
✓. Grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib;

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.

What they're measuring

incidence of grade 3-4 diarrhea

Timeframe: From the beginning of taking traditional Chinese medicine to the 21st day

Trial details

NCT IDNCT04988165

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-08

Contact for this trial

zhansheng jiang, doctor

022-23340123-1101 zhjiang@tmu.edu.cn

View on ClinicalTrials.gov More Diarrhea Caused by Antitumor Drugs trials