UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034853 |
|---|---|
| Receipt number | R000039324 |
| Scientific Title | Efficacy of hydrocolloid dressing for prophylactic use of hand-foot skin reaction induced by multi targeted kinase inhibitors: a phase III self-controlled study |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2023/11/16 16:33:23 |
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Basic information
Public title
Efficacy of hydrocolloid dressing for prophylactic use of hand-foot skin reaction induced by multi targeted kinase inhibitors: a phase III self-controlled study
Acronym
Apron trial
Scientific Title
Efficacy of hydrocolloid dressing for prophylactic use of hand-foot skin reaction induced by multi targeted kinase inhibitors: a phase III self-controlled study
Scientific Title:Acronym
Apron trial
Region
| Japan |
Condition
Condition
Colorectal cancer,Gastrointestinal Stromal Tumor,Hepatocellular carcinoma
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of hydrocolloid dressing for prevention of hand-foot syndrome for the colorectal cancer, GIST or hepatocellular carcinoma patients who receive multi-kinase inhibitor therapy comparing the standard supportive care of moisturizing only within the same individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of grade 2 or higher hand-foot syndrome (only sole)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In addition to the standard care of moisturizing, attach a hydrocolloid dressing for 1 month from the start of multi-kinase inhibitor therapy.
Interventions/Control_2
the standard care of moisturizing
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
1)Histologically confirmed colorectal cancer, GIST, or hepatocellular carcinoma
2)Unresectable advanced or recurrent colorectal cancer, GIST, hepatocellular carcinoma
3)Patients who will start either regorafenib or sorafenib, regardless of previous therapy
4)Age of 20 years and older
5)Performance status (PS) of 0 to 2
6)Patients without cognitive impairment and capable of linguistic communication
7)Without the skin lesions judged to be difficult to evaluate skin symptoms in the sole
Key exclusion criteria
1)Mental disease or psychiatric symptoms that interferes with daily life and judged to be difficult to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Asako |
| Middle name | |
| Last name | Ryu |
Organization
National Cancer Center Hospital
Division name
Nursing department
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
TEL
08061059481
asryu@ncc.go.jp
Public contact
Name of contact person
| 1st name | Asako |
| Middle name | |
| Last name | Ryu |
Organization
National Cancer Center Hospital
Division name
Nursing department
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
TEL
03-3542-2511
Homepage URL
https://www.j-support.org/study/index.html
asryu@ncc.go.jp
Sponsor or person
Institute
Japan Supportive, Palliative and Psychosocial Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kimura Foundation For Nursing Education
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
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
Tel
03-3542-2511
asryu@ncc.go.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
| 2018 | Year | 12 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 04 | 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
| 2018 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039324
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
