Diarrhea Caused by Antitumor Drugs
Conditions
Keywords
Diarrhea, Pyrotinib, Traditional Chinese Medicine
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.
Interventions
DRUGTraditional Chinese Medicine
It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Meet the following two conditions: 1. Planned administration of pyrotinib ≥ 21 days; 2. 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
<!-- --> 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary Contactzhansheng jiang, doctor
Backup Contactzhanyu pan, doctor
Outcome results
None listed