Back to resultsPrevention and Treatment of Pyrrolitinib-associated Diarrhea
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Loperamide
Loperamide and golden bifid
Loperamide and montmorillonite powder
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Diarrhea, Non-secondary prevention, Secondary prevention, pyrrolitinib
Eligibility Criteria
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:
- 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.
Sites / Locations
- TianJin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Loperamide
Loperamide and gold bifid
Loperamide and Montmorillonite SAN
Non-intervention
Arm Description
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21)
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D.
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D.
Do not intervene and stop diarrhea as needed
Outcomes
Primary Outcome Measures
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
The proportion of 3/4 degree diarrhea in group A From the first day of treatment to the 22nd day of treatment
Secondary prevention
Secondary Outcome Measures
Loperamide combined program, diarrhea recovery to level 0 or baseline time
Non-secondary prevention
3/4 degree incidence of diarrhea
Non-secondary prevention
The accumulated time of diarrhea during the follow-up period
Non-secondary prevention
Time of first occurrence of diarrhea
Non-secondary prevention
The incidence rate of all degrees of diarrhea during the follow-up period
Non-secondary prevention
The incidence of constipation of degree 2 or above during the follow-up period
Non-secondary prevention
Other AE/SAE during the follow-up period
Non-secondary prevention
The proportion of cases with 3/4 degree diarrhea
secondary prevention
The proportion of incidences of 3/4 degree diarrhea during follow-up
secondary prevention
The incidence rate of all degrees of diarrhea during the follow-up period
secondary prevention
The incidence of constipation of degree 2 or above during the follow-up period
secondary prevention
The time of the first diarrhea attack during the follow-up period
secondary prevention
The cumulative duration of diarrhea during the follow-up period
secondary prevention
Proportion of subjects with delayed or reduced doses of pyrrolitinib due to diarrhea
secondary prevention
Other AE/SAE during the follow-up period
secondary prevention
Full Information
NCT ID
NCT04736186
First Posted
September 22, 2020
Last Updated
January 28, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04736186
Brief Title
Prevention and Treatment of Pyrrolitinib-associated Diarrhea
Official Title
Prevention and Treatment of Pyrrolitinib-associated Diarrhea: a Prospective, Multicenter, Open-label Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Diarrhea, Non-secondary prevention, Secondary prevention, pyrrolitinib
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Loperamide
Arm Type
Experimental
Arm Description
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21)
Arm Title
Loperamide and gold bifid
Arm Type
Experimental
Arm Description
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D.
Arm Title
Loperamide and Montmorillonite SAN
Arm Type
Experimental
Arm Description
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D.
Arm Title
Non-intervention
Arm Type
No Intervention
Arm Description
Do not intervene and stop diarrhea as needed
Intervention Type
Drug
Intervention Name(s)
Loperamide
Intervention Description
Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)
Intervention Type
Drug
Intervention Name(s)
Loperamide and golden bifid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Loperamide and montmorillonite powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The proportion of 3/4 degree diarrhea in group A From the first day of treatment to the 22nd day of treatment
Description
Secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Secondary Outcome Measure Information:
Title
Loperamide combined program, diarrhea recovery to level 0 or baseline time
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
3/4 degree incidence of diarrhea
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The accumulated time of diarrhea during the follow-up period
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
Time of first occurrence of diarrhea
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The incidence rate of all degrees of diarrhea during the follow-up period
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The incidence of constipation of degree 2 or above during the follow-up period
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
Other AE/SAE during the follow-up period
Description
Non-secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The proportion of cases with 3/4 degree diarrhea
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The proportion of incidences of 3/4 degree diarrhea during follow-up
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The incidence rate of all degrees of diarrhea during the follow-up period
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The incidence of constipation of degree 2 or above during the follow-up period
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The time of the first diarrhea attack during the follow-up period
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
The cumulative duration of diarrhea during the follow-up period
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
Proportion of subjects with delayed or reduced doses of pyrrolitinib due to diarrhea
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
Other AE/SAE during the follow-up period
Description
secondary prevention
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Other Pre-specified Outcome Measures:
Title
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）
Description
exploratory，descriptive results
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
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）
Description
exploratory，descriptive results
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
Title
Efficacy of pyrrolitinib (According to the curative effect evaluation standard of solid tumor version 1.1, the imaging curative effect of tumor was evaluated）
Description
exploratory，descriptive results
Time Frame
From the first day of treatment to the 22nd day of treatment(about 21 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong MD Liu, professor
Phone
18622221169
Email
lh713@163.com
Facility Information:
Facility Name
TianJin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong MD Liu, professor
Phone
18622221169
Email
lh713@163.com
12. IPD Sharing Statement
Learn more about this trial
Prevention and Treatment of Pyrrolitinib-associated Diarrhea
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