Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
October 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2022
CompletedAugust 11, 2021
July 1, 2021
1 year
July 31, 2021
August 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Treatment arm
EXPERIMENTALInterventions
It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.
Eligibility Criteria
You may qualify if:
- \. 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;
- \. Age ≥ 18 years old;
- \. ECOG PS 0-2；
- \. Life expectancy ≥ 6 months;
- \. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up
You may not qualify if:
- <!-- -->
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
zhongsheng tong, doctor
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2021
First Posted
August 3, 2021
Study Start
October 8, 2021
Primary Completion
October 8, 2022
Study Completion
October 8, 2022
Last Updated
August 11, 2021
Record last verified: 2021-07