Clinical trial NCT04988165: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diarrhea Caused by Antitumor Drugs
Keywords: Diarrhea
Pyrotinib
Traditional Chinese Medicine
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

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  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.

Primary outcomes:
measure: incidence of grade 3-4 diarrhea
timeFrame: From the beginning of taking traditional Chinese medicine to the 21st day
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: zhongsheng tong, doctor
role: STUDY_DIRECTOR
References: