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

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04988165
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Traditional Chinese Medicine
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
Anticipated Study Start Date :
Oct 8, 2021
Anticipated Primary Completion Date :
Oct 8, 2022
Anticipated Study Completion Date :
Oct 8, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. incidence of grade 3-4 diarrhea [From the beginning of taking traditional Chinese medicine to the 21st day]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  3. Age ≥ 18 years old;

  4. ECOG PS 0-2；

  5. Life expectancy ≥ 6 months;

  6. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060

Sponsors and Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT04988165
Other Study ID Numbers:
  • TCM-padia001
First Posted:
Aug 3, 2021
Last Update Posted:
Aug 11, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital
Diarrhea
Pyrotinib
Traditional Chinese Medicine
Additional relevant MeSH terms:
Diarrhea

Study Results

No Results Posted as of Aug 11, 2021