UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039509 |
|---|---|
| Receipt number | 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 | 2024/08/20 11:33:55 |
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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)
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
taharay@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
https://www.sciencedirect.com/science/article/abs/pii/S1462388924000747
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1462388924000747
Number of participants that the trial has enrolled
60
Results
We analyzed the feet (n = 110) of 55 patients, excluding 5 who withdrew or had data loss, from 60 subjects. The feet were categorized into low-HFSR (grade < 2) and high-HFSR (grade >= 2) groups. No significant differences were found between the groups in a t-test (p >= 0.05). However, Cox hazard analysis adjusted for HFSR-related factors indicated that higher peak shear stress on the 5th metatarsal head increased the risk of HFSR (hazard ratio = 1.01, p = 0.047; 95% CI = 1.00-1.02).
Results date posted
| 2024 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included patients who received lenvatinib, sorafenib, or regorafenib as treatment for hepatocellular carcinoma.Patients aged 20 years or older, who were able to walk without assistance, who did not have mental symptoms, who understood the explanation of the study, and who provided written informed consent to participate in the care of their doctor were included in the study.
Participant flow
HFSR classification was performed based on interviews and photographs of the hands and feet. The follow-up period was set at two months after the start of treatment, during which interviews and photographs were taken at each visit. External forces applied to the soles of the feet were measured before the start of treatment. A button-type sensor was attached to the second and fifth metatarsal heads, and the measurement was conducted while the patients walked 15 meters wearing their own shoes.
Adverse events
No adverse events were observed.
Outcome measures
Peak pressure, pressure time integral, peak shear stress and shear stress time integral at the second and fifth metatarsal heads
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045013
