Prevention and Treatment of Pyrrolitinib-associated Diarrhea
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT04736186
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 470
-
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.
- May be allergic to pyrrolitinib or excipients;
- There are many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting;
- Patients with biliary obstruction;
- Participate in other diarrhea-related clinical trials;
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Loperamide and Montmorillonite SAN Loperamide and montmorillonite powder Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D. Loperamide Loperamide Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) Loperamide and gold bifid Loperamide Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D. Loperamide and gold bifid Loperamide and golden bifid Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D. Loperamide and Montmorillonite SAN Loperamide Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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) 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) 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) 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
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
Trial Locations
- Locations (1)
TianJin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, China