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Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine

Primary Purpose

Diarrhea Caused by Antitumor Drugs

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Traditional Chinese Medicine
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea Caused by Antitumor Drugs focused on measuring Diarrhea, Pyrotinib, Traditional Chinese Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Meet the following two conditions:

    1. Planned administration of pyrotinib ≥ 21 days;

    2. Grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib;

      2. Age ≥ 18 years old;

      3. ECOG PS 0-2；

      4. Life expectancy ≥ 6 months;

      5. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up

      Exclusion Criteria:

    1. Those who may be allergic to pyrotinib or excipients;
    2. It has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc;
    3. Patients with biliary obstruction;
    4. Participate in other diarrhea related clinical trials;
    5. 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;
    6. 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).
    7. Any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2021
Last Updated
August 3, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04988165
Brief Title
Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
Official Title
Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2021 (Anticipated)
Primary Completion Date
October 8, 2022 (Anticipated)
Study Completion Date
October 8, 2022 (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

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea Caused by Antitumor Drugs
Keywords
Diarrhea, Pyrotinib, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Traditional Chinese Medicine
Intervention Description
It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.
Primary Outcome Measure Information:
Title
incidence of grade 3-4 diarrhea
Description
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
Time Frame
From the beginning of taking traditional Chinese medicine to the 21st day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. Age ≥ 18 years old; 3. ECOG PS 0-2； 4. Life expectancy ≥ 6 months; 5. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhansheng jiang, doctor
Phone
022-23340123-1101
Email
zhjiang@tmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
zhanyu pan, doctor
Phone
022-23340123-1101
Email
s0010027@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhongsheng tong, doctor
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanyu Pan, Master
Phone
86-13512035574
Ext
1392029
Email
s0010027@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD is under construction

Learn more about this trial

Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine

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