Evaluation of prophylactic administration of Loperamide for Diarrhea Treated with Abemaciclib in Breast Cancer Patients

JRCT ID: jRCT1041240134

Registered date:27/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 19/12/2024
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Administer 1 mg of loperamide at the onset of the first episode of diarrhea following abemaciclib administration. Subsequently, administer 0.5 mg of loperamide concurrently with abemaciclib.

Outcome(s)

• Primary Outcome: Percentage (%) of abemaciclib dose reduction cases due to diarrhea in patients who received prophylactic loperamide for the prevention of abemaciclib-induced diarrhea.

Secondary Outcome

1)Total dose of loperamide administered from Day 1 to Day 28 (mg)
2)Adverse events other than diarrhea (Grade 3 or higher)
3)Percentage of cases with abemaciclib dose reduction due to adverse events other than diarrhea

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with hormone receptor-positive, HER2-negative breast cancer who have no prior history of abemaciclib treatment and are introducing abemaciclib therapy.
2)Patients aged 18 years or older at the time of signing the informed consent form.
3)Patients with an ECOG Performance Status (ECOG PS) of 0 to 2 at the time of enrollment.
4)Patients whose clinical laboratory values meet the following criteria (CTCAE v5.0) in the latest tests prior to enrollment
(1) AST (GOT) Grade 1 or lower
(2) ALT (GPT) Grade 1 or lower
5)Patients who are able to comply with the requirements of the study protocol.
6)Patients who have understood the contents of the informed consent document and voluntarily provided written consent.

Exclude criteria

1)Patients with severe complications (e.g., interstitial pneumonia, pulmonary fibrosis, uncontrolled hypertension, uncontrolled diabetes mellitus).
2)Patients with serious infections (including active tuberculosis).
3)Patients with hypersensitivity to the investigational drug.
4)Patients with a history of obstructive bowel disease, such as ileus.
5)Patients with hemorrhagic colitis, infectious diarrhea, or pseudomembranous colitis induced by antibiotic treatment.
6)Patients with pre-existing diarrhea symptoms due to other conditions (e.g., ulcerative colitis, Crohn's disease) prior to the initiation of abemaciclib.
7)Pregnant or breastfeeding patients, patients who might be pregnant, or patients unwilling to use contraception.
8)Patients using medications that are contraindicated in this trial.
9)Patients deemed inappropriate by the principal investigator (or sub-investigator).

Related Information

• Primary Sponsor: Hara Fumitaka