UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057740 |
|---|---|
| Receipt number | R000065109 |
| Scientific Title | Evaluation of Home Blood Pressure in Patients Undergoing Anticancer Drug Therapy |
| Date of disclosure of the study information | 2025/04/29 |
| Last modified on | 2025/10/30 16:25:30 |
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Basic information
Public title
Evaluation of Home Blood Pressure in Patients Undergoing Anticancer Drug Therapy - Feasibility Study: A Multicenter Observational Study
Acronym
Evaluation of Home Blood Pressure in Patients Undergoing Anticancer Drug Therapy
Scientific Title
Evaluation of Home Blood Pressure in Patients Undergoing Anticancer Drug Therapy
Scientific Title:Acronym
Evaluation of Home Blood Pressure in Patients Undergoing Anticancer Drug Therapy
Region
| Japan |
Condition
Condition
Patients with Malignant Tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate home blood pressure measurements taken twice daily (morning and evening) in patients undergoing anticancer drug therapy, with the aim of establishing appropriate hypertension management guidelines. This study serves as a preliminary investigation for a future large-scale multicenter collaborative study.
Basic objectives2
Others
Basic objectives -Others
The changes in home blood pressure levels during treatment remain unclear in cancer patients undergoing therapies that may induce treatment-related hypertension or accelerate atherosclerosis.
This study aims to improve clinical outcomes by evaluating changes in home blood pressure levels during treatment in cancer patients through collaboration between oncologists and cardiologists. Additionally, it serves as a preliminary investigation for a planned large-scale, multicenter collaborative study aimed at establishing guidelines for hypertension management. The findings will provide valuable insights into the rapidly evolving field of onco-cardiology.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure values (Comparison of clinic blood pressure and home blood pressure in patients undergoing anticancer drug therapy)
Key secondary outcomes
Blood biochemical tests, urinalysis (common general clinical parameters), adverse event evaluation, and questionnaire surveys will be conducted to:
- Assess the relationship between the difference in clinic blood pressure and home blood pressure during anticancer drug therapy, as well as the longitudinal changes in home blood pressure and urinary protein excretion (g/gCre) and estimated daily salt intake.
- Evaluate the relationship between longitudinal changes in home blood pressure and medication status during anticancer drug therapy.
- Assess the dropout rate and adherence rate of home blood pressure measurements.
- Evaluate the relationship between longitudinal changes in various parameters and medication status during anticancer drug therapy.
Additionally, as exploratory outcomes, we will examine whether longitudinal changes in home blood pressure during anticancer drug therapy are associated with adverse events and changes in questionnaire survey results over time.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients diagnosed with a malignant tumor
- Patients who are initiating or currently undergoing treatment with an oral anti-angiogenic agent (anti-cancer drug), including those receiving combination therapy with non-pharmacological treatments such as surgery or radiation therapy, as well as those with a history of hypertension
- Patients capable of measuring home blood pressure (i.e., those who own an upper-arm cuff blood pressure monitor)
Key exclusion criteria
- Individuals with an ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) of 3 or higher
- Individuals deemed unsuitable for inclusion by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Hospital
Division name
Yokohama City University Hospital
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2800
minegishi.shi.fb@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Morimoto |
Organization
Tokyo Women's Medical University Adachi Medical Center
Division name
Division of Medicine
Zip code
123-8558
Address
4-33-1 Kohhoku, Adachi-ku, Tokyo
TEL
03-3757-0111
Homepage URL
morimoto.satoshi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Satoshi Morimoto
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethical Committee for Medical and Health Research Involving Human Subjects
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
Tel
045-370-7627
rinri@yokohama-cu.ac.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 | 04 | Month | 29 | 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
| 2024 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe blood pressure values (comparing office blood pressure and home blood pressure during anti-cancer drug treatment)
Management information
Registered date
| 2025 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065109
