Prevention and Treatment of Pyrrolitinib-associated Diarrhea

NCT04736186 | Unknown Phase 2 DMC

• 1 other identifier: YWBC-002
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Diarrhea; Non-secondary prevention; Secondary prevention; pyrrolitinib

Outcome Measures

Primary Outcomes (2)

• 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

  From the first day of treatment to the 22nd day of treatment(about 21 days)

• The proportion of 3/4 degree diarrhea in group A From the first day of treatment to the 22nd day of treatment

  Secondary prevention

  From the first day of treatment to the 22nd day of treatment(about 21 days)

Secondary Outcomes (15)

• Loperamide combined program, diarrhea recovery to level 0 or baseline time

  From the first day of treatment to the 22nd day of treatment(about 21 days)

• 3/4 degree incidence of diarrhea

  From the first day of treatment to the 22nd day of treatment(about 21 days)

• The accumulated time of diarrhea during the follow-up period

  From the first day of treatment to the 22nd day of treatment(about 21 days)

• Time of first occurrence of diarrhea

  From the first day of treatment to the 22nd day of treatment(about 21 days)

• The incidence rate of all degrees of diarrhea during the follow-up period

  From the first day of treatment to the 22nd day of treatment(about 21 days)

Other Outcomes (3)

• 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）

  From the first day of treatment to the 22nd day of treatment(about 21 days)

• 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）

  From the first day of treatment to the 22nd day of treatment(about 21 days)

• Efficacy of pyrrolitinib (According to the curative effect evaluation standard of solid tumor version 1.1, the imaging curative effect of tumor was evaluated）

  From the first day of treatment to the 22nd day of treatment(about 21 days)

Study Arms (4)

Loperamide

EXPERIMENTAL

Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21)

Drug: Loperamide

Loperamide and gold bifid

EXPERIMENTAL

Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D.

Drug: Loperamide; Drug: Loperamide and golden bifid

Loperamide and Montmorillonite SAN

EXPERIMENTAL

Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D.

Drug: Loperamide; Drug: Loperamide and montmorillonite powder

Non-intervention

NO INTERVENTION

Do not intervene and stop diarrhea as needed

Interventions

Loperamide DRUG

Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)

Loperamide; Loperamide and Montmorillonite SAN; Loperamide and gold bifid

Loperamide and golden bifid DRUG

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.

Loperamide and gold bifid

Loperamide and montmorillonite powder DRUG

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.

Loperamide and Montmorillonite SAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

TianJin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Diarrhea

Interventions

Loperamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hong MD Liu, professor

CONTACT

18622221169; lh713@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: February 3, 2021
• Study Start: May 16, 2020
• Primary Completion: October 31, 2022
• Study Completion: April 30, 2023
• Last Updated: February 3, 2021

Record last verified: 2020-05

Locations

CN (1)