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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loperamide | Experimental | Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) |
|
| Loperamide and gold bifid | Experimental | Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D. |
|
| Loperamide and Montmorillonite SAN | Experimental | Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D. |
|
| Non-intervention | No Intervention | Do not intervene and stop diarrhea as needed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loperamide | Drug | Loperamide 4 mg, t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Non-secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The proportion of 3/4 degree diarrhea in group A From the first day of treatment to the 22nd day of treatment | Secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Loperamide combined program, diarrhea recovery to level 0 or baseline time | Non-secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| 3/4 degree incidence of diarrhea |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | exploratory,descriptive results | From the first day of treatment to the 22nd day of treatment(about 21 days) |
Inclusion Criteria:
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;
Age ≥18 years;
ECOG PS 0-2;
Life expectancy ≥6 months;
Participate in this study voluntarily, sign informed consent, have good compliance and are willing to cooperate with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong MD Liu, professor | Contact | 18622221169 | lh713@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TianJin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | 300060 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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).
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| Loperamide and golden bifid | Drug | 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. |
|
| Loperamide and montmorillonite powder | Drug | 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. |
|
Non-secondary prevention
| From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The accumulated time of diarrhea during the follow-up period | Non-secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| Time of first occurrence of diarrhea | Non-secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The incidence rate of all degrees of diarrhea during the follow-up period | Non-secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The incidence of constipation of degree 2 or above during the follow-up period | Non-secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| Other AE/SAE during the follow-up period | Non-secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The proportion of cases with 3/4 degree diarrhea | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The proportion of incidences of 3/4 degree diarrhea during follow-up | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The incidence rate of all degrees of diarrhea during the follow-up period | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The incidence of constipation of degree 2 or above during the follow-up period | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The time of the first diarrhea attack during the follow-up period | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| The cumulative duration of diarrhea during the follow-up period | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| Proportion of subjects with delayed or reduced doses of pyrrolitinib due to diarrhea | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| Other AE/SAE during the follow-up period | secondary prevention | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| 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) |
exploratory,descriptive results |
| From the first day of treatment to the 22nd day of treatment(about 21 days) |
| Efficacy of pyrrolitinib (According to the curative effect evaluation standard of solid tumor version 1.1, the imaging curative effect of tumor was evaluated) | exploratory,descriptive results | From the first day of treatment to the 22nd day of treatment(about 21 days) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |