Breast Cancer
Conditions
Keywords
Diarrhea, Non-secondary prevention, Secondary prevention, pyrrolitinib
Brief summary
In this study, patients taking pyrrolitinib alone or combined with pyrrolitinib were recruited (170 cases of secondary prevention and 300 cases of non-secondary prevention). Non-secondary prevention: Explore the recovery time of oral loperamide 4mg T.I.D. for pyrrolitinib induced diarrhea of 1-2 degrees. Secondary prevention: To explore the incidence of grade 3 and above diarrhea during c1D1-C1D22 in patients with oral loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21).
Detailed description
The study can only be formally carried out with the written approval of the ethics committee. Investigators regularly submit annual research reports to the ethics committee. Investigators will inform the ethics committee in writing when the study is discontinued and / or completed. All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation. In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.
Interventions
DRUGLoperamide
Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)
DRUGLoperamide and golden bifid
Patients with secondary prevention will be randomly assigned to B：Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)+golden bifid 2 g t.i.d.
DRUGLoperamide and montmorillonite powder
Patients with secondary prevention will be randomly assigned to D：Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)+montmorillonite powder 3 g t.i.d.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Non-secondary prevention: Explore the recovery time of oral loperamide 4mg T.I.D. for pyrrolitinib induced diarrhea of 1-2 degrees. Secondary prevention: To explore the incidence of grade 3 and above diarrhea during c1D1-C1D22 in patients with oral loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. One of the following two situations: A) Plan to take pyrrolitinib for ≥21 days; B) Third-degree diarrhea or second-degree diarrhea with complications after taking pyrrolitinib at present, plan to take pyrrolitinib for ≥21 days; 2. Age ≥18 years; 3. ECOG PS 0-2; 4. Life expectancy ≥6 months; 5. Participate in this study voluntarily, sign informed consent, have good compliance and are willing to cooperate with the follow-up.
Exclusion criteria
1. May be allergic to pyrrolitinib or excipients; 2. There are many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting; 3. Patients with biliary obstruction; 4. Participate in other diarrhea-related clinical trials; 5. Pregnant and lactating women, fertile women who tested positive in the baseline pregnancy test, or women of childbearing age who were unwilling to use effective contraception during the whole trial period; 6. Concomitant diseases (including but not limited to severe hypertension beyond the control of drugs, severe diabetes, etc.) that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study; The investigator concluded that the patient was not eligible for any of the other conditions in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time from the first day of treatment until diarrhea returns to level 0 or baseline during the first day of treatment to the 22nd day of treatment | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| The proportion of 3/4 degree diarrhea in group A From the first day of treatment to the 22nd day of treatment | From the first day of treatment to the 22nd day of treatment(about 21 days) | Secondary prevention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3/4 degree incidence of diarrhea | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| The accumulated time of diarrhea during the follow-up period | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| Time of first occurrence of diarrhea | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| The incidence rate of all degrees of diarrhea during the follow-up period | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| The incidence of constipation of degree 2 or above during the follow-up period | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| Loperamide combined program, diarrhea recovery to level 0 or baseline time | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| The time of the first diarrhea attack during the follow-up period | From the first day of treatment to the 22nd day of treatment(about 21 days) | secondary prevention |
| The cumulative duration of diarrhea during the follow-up period | From the first day of treatment to the 22nd day of treatment(about 21 days) | secondary prevention |
| Proportion of subjects with delayed or reduced doses of pyrrolitinib due to diarrhea | From the first day of treatment to the 22nd day of treatment(about 21 days) | secondary prevention |
| Other AE/SAE during the follow-up period | From the first day of treatment to the 22nd day of treatment(about 21 days) | Non-secondary prevention |
| The proportion of cases with 3/4 degree diarrhea | From the first day of treatment to the 22nd day of treatment(about 21 days) | secondary prevention |
| The proportion of incidences of 3/4 degree diarrhea during follow-up | From the first day of treatment to the 22nd day of treatment(about 21 days) | secondary prevention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Risk factor analysis for diarrhea（The baseline information, demographic data, past treatment history, treatment plan and diet habits of patients with diarrhea were summarized, and the risk factors of diarrhea were summarized） | From the first day of treatment to the 22nd day of treatment(about 21 days) | exploratory，descriptive results |
| Efficacy of pyrrolitinib (According to the curative effect evaluation standard of solid tumor version 1.1, the imaging curative effect of tumor was evaluated） | From the first day of treatment to the 22nd day of treatment(about 21 days) | exploratory，descriptive results |
| Analysis of intestinal flora（During the experiment, the feces were collected three times for microbiological examination, and the results of microbiological examination were summarized and analyzed to understand the types of microbiota） | From the first day of treatment to the 22nd day of treatment(about 21 days) | exploratory，descriptive results |
Countries
China
Contacts
Primary ContactHong MD Liu, professor
Outcome results
None listed