UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015857 |
|---|---|
| Receipt number | R000017784 |
| Scientific Title | Research on a Quantitative Assessment of Skin Symptoms Caused by Chemotherapy Using Molecular Target Drugs |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2016/12/15 22:17:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on a Quantitative Assessment of Skin Symptoms Caused by Chemotherapy Using Molecular Target Drugs
Acronym
Quantitative Assessment of Skin Symptoms Caused by Chemotherapy Using Molecular Target Drugs
Scientific Title
Research on a Quantitative Assessment of Skin Symptoms Caused by Chemotherapy Using Molecular Target Drugs
Scientific Title:Acronym
Quantitative Assessment of Skin Symptoms Caused by Chemotherapy Using Molecular Target Drugs
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer and colorectal cancer
Classification by specialty
| Gastroenterology | Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to assess multilateral changes of skin symptoms caused by chemotherapy using molecular target drugs quantitatively. The study also uses a qualitative grading evaluation and QOL questionnaires and examines the effectiveness of the assessments.
Basic objectives2
Others
Basic objectives -Others
To assess successive changes in skin symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Assessment by devices>
1) Transepidermal water loss
2) Capacitance (stratum corneum-epidermal water)
3) Erythema & melanin index
4) Visia (Facial skin condition)
<Visual assessment>
NCI-CTC (ver. 4.0 Japanese version JCOG)
<Self-completed questionnaires>
Skindex 29 (QOL regarding skin symptoms)
Key secondary outcomes
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Non-small-cell lung cancer patients who are treated with afatinib (giotrif) or erlotinib (tarceva) and colorectal cancer patients who are treated with cetuximab (erbitax).
2) PS is from 0 to 1.
3) Patients who agreed to participate in this study.
Key exclusion criteria
1) Patients who have skin symptoms that influence skin functions such as atopic dermatitis.
2) Patients who receive treatments that influence skin functions such as steroids and antibacterial drugs.
3) Patients who are unable to control dependence.
4) Patients who are unable to respond to self-completed questionnaires.
5) Physicians decide it is inappropriate for the patients to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Nozawa |
Organization
National Cancer Center Hospital
Division name
Appearance Support Center
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
TEL
03-3547-5201(3015)
knozawa@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Nozawa |
Organization
National Cancer Center Hospital
Division name
Appearance Support Center
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
TEL
03-3547-5201(3015)
Homepage URL
knozawa@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Appearance Support Center
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grants 2014
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mie University
Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 12 | Month | 05 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
This study evaluates skin symptoms caused by molecular target drugs and QOL quantitatively and qualitatively.
Management information
Registered date
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2016 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017784
