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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039509
Receipt No. R000045013
Scientific Title Factors of hand-foot skin reacion associated with multi kinase inhibitor for hepatocellular carcinoma
Date of disclosure of the study information 2020/02/18
Last modified on 2020/02/17

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Basic information
Public title Factors of hand-foot skin reacion associated with multi kinase inhibitor for hepatocellular carcinoma
Acronym Factors of hand-foot skin reacion associated with multi kinase inhibitor for hepatocellular carcinoma
Scientific Title Factors of hand-foot skin reacion associated with multi kinase inhibitor for hepatocellular carcinoma
Scientific Title:Acronym Factors of hand-foot skin reacion associated with multi kinase inhibitor for hepatocellular carcinoma
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Reveal the factors of hand-foot skin reaction in the sole of the foot
Basic objectives2 Others
Basic objectives -Others Reveal the occurrence rate of hand-foot skin reaction in the palmar and sole
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Factors of hand-foot skin reaction in the sole of the foot for two months after starting treatment
Key secondary outcomes clinical data, number of steps, foot deformities, shoe shape, external force applied to foot, self-care implementation

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 The patients who treated by lenvatinib, sorafenib and regorafenib for unresectable hepatocellular carcinoma
Key exclusion criteria 1. Under 20 years old
2. Not have the ability to walk by themselves
3. Who could not obtain the concent to participate in this study within one week after starting treatment
4. Have severe mental disorders (such as severe depression)
5. Not have the ability of informed concent
6. Be decided to unsuitable for the study by his/her doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yukie
Middle name
Last name Tahara
Organization Graduate School of Nursing, Chiba University
Division name Department of Nursing Physiology
Zip code 260-8672
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8672
TEL 043-222-7171(ext.5711)
Email taharay@chiba-u.jp

Public contact
Name of contact person
1st name Yukie
Middle name
Last name Tahara
Organization Graduate School of Nursing, Chiba University
Division name Department of Nursing Physiology
Zip code 260-8672
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8672
TEL 043-222-7171(ext.5711)
Homepage URL
Email taharay@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Yamaji Fumiko Nursing Research Fund
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of the Graduate School of Nursing, Chiba University
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8672
Tel 043-222-7171
Email kango-rinri@chiba-u.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
2020 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 60
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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
2018 Year 07 Month 06 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Study design
Cohort study

2.Recruiting
Patients who visited the facility from October 2018 to March 2020 and matched the selection criteria

3.Variable
age, gender, height, weight, PS, Child-Pugh score, absence of metastasis, metastatic organ, treatment history, laboratory data, kind of anticancer drug, treatment period, dosage, side effects other than HFSR, foot length, foot width, hallux valgus angle, ground contact area, foot circumference, inner and inner width of shoe, inner circumference, shoe type, sole pressure, shear stress, skin thickening, foot deformation, step count, self-care for HFSR, occurrence of HFSR, location, symptoms, severity, timing

Management information
Registered date
2020 Year 02 Month 17 Day
Last modified on
2020 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045013

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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