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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034853
Receipt No. R000039324
Official scientific title of the study 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 2018/11/10

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Basic information
Official scientific title of the study Efficacy of hydrocolloid dressing for prophylactic use of hand-foot skin reaction induced by multi targeted kinase inhibitors: a phase III self-controlled study


Title of the study (Brief title) 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 Asako Ryu
Organization National Cancer Center Hospital
Division name Nursing department
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
TEL 03-3542-2511
Email asryu@ncc.go.jp

Public contact
Name of contact person Asako Ryu
Organization National Cancer Center Hospital
Division name Nursing department
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
Email asryu@ncc.go.jp

Sponsor
Institute Japan Supportive, Palliative and Psychosocial Oncology Group
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 30 Day
Anticipated trial start date
2018 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 10 Day
Last modified on
2018 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039324

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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