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

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.

Study Overview

• Status: Recruiting
• Conditions: Diarrhea Caused by Antitumor Drugs
• Intervention / Treatment: Drug: Traditional Chinese Medicine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: zhansheng jiang, doctor; Phone Number: 022-23340123-1101; Email: zhjiang@tmu.edu.cn
• Study Contact Backup: Name: zhanyu pan, doctor; Phone Number: 022-23340123-1101; Email: s0010027@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Zhanyu Pan, Master; Phone Number: 1392029 86-13512035574; Email: s0010027@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm	Drug: Traditional Chinese Medicine; It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the beginning of taking traditional Chinese medicine to the 21st day

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Director: zhongsheng tong, doctor, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 8, 2021
• Primary Completion (Anticipated): October 8, 2022
• Study Completion (Anticipated): October 8, 2022

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Diarrhea; Traditional Chinese Medicine; Pyrotinib
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: TCM-padia001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD is under construction

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No