UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060032 |
|---|---|
| Receipt number | R000068658 |
| Scientific Title | Abemaciclib-induced diarrhea and loperamide use during the second and third cycles of abemaciclib: a single-center prospective observational study (AID2 study) |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/10 00:31:08 |
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Basic information
Public title
Investigation of abemaciclib-induced diarrhea during the second and third cycles of abemaciclib
Acronym
AID2 study
Scientific Title
Abemaciclib-induced diarrhea and loperamide use during the second and third cycles of abemaciclib: a single-center prospective observational study (AID2 study)
Scientific Title:Acronym
AID2 study
Region
| Japan |
Condition
Condition
Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced/Recurrent or Adjuvant)
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to describe the occurrence of abemaciclib-induced diarrhea (AID) and the actual use of loperamide during the second and third cycles of abemaciclib in patients with hormone receptor-positive, HER2-negative breast cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of Bristol stool scale type 6 or 7 bowel movements per day
Key secondary outcomes
<Diarrhea-related>
- Number of days with Bristol stool scale type 6 or 7 bowel movements and their proportion among all observation days
- Proportion of patients with Bristol stool scale type 6 or 7 bowel movements
- Proportion of patients with grade 2 or higher diarrhea
<Loperamide use>
- Total dose of loperamide and total number of loperamide administrations
- Proportion of days with loperamide use among days with Bristol Stool Scale type 6 or 7 bowel movements
- Proportion of days with scheduled loperamide 1 mg twice daily among days with Bristol Stool Scale type 6 or 7 bowel movements and loperamide use
<Others(safety, treatment continuation, and quality of life)>
- Proportion of patients with grade 2 or higher constipation
- Proportions of patients with dose omission, dose reduction, or discontinuation of abemaciclib primarily due to diarrhea
- Changes in EORTC QLQ-C30 scores (diarrhea, physical functioning, and global health status/QoL scales)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 receiving abemaciclib treatment
- Patients who were enrolled in the previous AID1 study and completed the first-cycle observation period of abemaciclib
- Patients who are expected to continue abemaciclib through the third cycle at the time of enrollment in AID2
- Patients aged 20 years or older
- Patients with an ECOG Performance Status (PS) of 0 to 2
- Patients deemed by the principal investigator to be able to complete the study diary and questionnaires and to participate in this study
Key exclusion criteria
- Patients who did not complete treatment or observation during the first cycle of abemaciclib in the AID1 study
- 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
- 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 who have grade 2 or higher diarrhea at the time of enrollment in AID2 that is considered unrelated to abemaciclib
- Patients deemed inappropriate for participation in this study by the principal investigator
Target sample size
20
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 | 12 | Month | 10 | 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 | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study (AID2) enrolls patients who participated in the previous study, "Exploratory Single-Arm Interventional Study of Scheduled, Continued Loperamide for Abemaciclib-Induced Diarrhea: Evaluation of Diarrhea and Impact on Daily Activities" (AID1 study).
The UMIN trial ID of the AID1 study is UMIN000059172
Management information
Registered date
| 2025 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068658
