UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059172 |
|---|---|
| Receipt number | R000067679 |
| Scientific Title | Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities |
| Date of disclosure of the study information | 2025/09/24 |
| Last modified on | 2025/09/24 01:15:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities
Acronym
Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities
Scientific Title
Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities
Scientific Title:Acronym
Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities
Region
| Japan |
Condition
Condition
Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced/Recurrent or Adjuvant Setting)
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the efficacy and safety of scheduled, continued loperamide administration for abemaciclib-induced diarrhea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative number of Bristol Stool Scale type 6 or 7 bowel movements per patient over 28 days
Key secondary outcomes
<Diarrhea-related>
- Weekly cumulative number of Bristol Stool Scale type 6 or 7 bowel movements per patient
- Number of days with diarrhea (Bristol Stool Scale type 6 or 7) per patient over 28 days
- Incidence of diarrhea (Bristol Stool Scale type 6 or 7)
- Incidence of diarrhea of Grade 2 or higher
- Incidence of constipation of Grade 2 or higher
- Loperamide adherence rate (number of days taken / planned dosing days)
<Daily activities / QOL-related>
- Interference with daily activities due to diarrhea (proportion of patients affected, number of weeks affected, and weekly interference rates)
- Proportion of patients experiencing interference with daily activities in association with maximum CTCAE Grade 1 diarrhea (weekly and over 28 days)
- Changes in EORTC QLQ-C30 scores (focusing on diarrhea, physical functioning, and global QOL)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
When loose stools (Bristol Stool Scale type 6 or 7) occur after initiation of abemaciclib, loperamide 1 mg twice daily will be administered and continued with the same dosing schedule until Day 28, even after improvement of diarrhea.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients with hormone receptor-positive, HER2-negative breast cancer who are scheduled to start abemaciclib treatment
- Patients aged 20 years or older
- Patients with an ECOG Performance Status (PS) of 0 to 2
- Patients with no prior treatment with abemaciclib
- Patients with adequate organ function, as assessed by the treating physician
Key exclusion criteria
- Patients receiving concomitant medications contraindicated with abemaciclib or loperamide
- Patients with active infections
- Patients with infectious or hemorrhagic enteritis, or pseudomembranous colitis
- Pregnant or lactating women, and women of childbearing potential who are unwilling to use effective contraception n
- Patients with a history of obstructive bowel disease
- Patients with inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or a history thereof
- Patients with diarrhea of CTCAE Grade 2 or higher at baseline
- Patients deemed inappropriate for study participation by the treating physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Kawada |
Organization
Yokohama Asahi Chuo General Hospital
Division name
Department of Pharmacy
Zip code
241-0801
Address
4-20-1 Wakabadai, Asahi-ku, Yokohama, Kanagawa, Japan
TEL
0459216111
kawadashirokawada@gmail.com
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Kawada |
Organization
Yokohama Asahi Chuo General Hospital
Division name
Department of Pharmacy
Zip code
241-0801
Address
4-20-1 Wakabadai, Asahi-ku, Yokohama, Kanagawa, Japan
TEL
0459216111
Homepage URL
kawadashirokawada@gmail.com
Sponsor or person
Institute
Yokohama Asahi Chuo General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama Asahi Chuo General Hospital
Address
4-20-1 Wakabadai, Asahi-ku, Yokohama, Kanagawa, Japan
Tel
0459216111
cds122@crest.ocn.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067679
