UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on a Quantitative Assessment of Skin Symptoms Caused by Chemotherapy Using Molecular Target Drugs
Title of the study (Brief title)	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	Keiko Nozawa
Organization	National Cancer Center Hospital
Division name	Appearance Support Center
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
TEL	03-3547-5201(3015)
Email	knozawa@ncc.go.jp

Public contact
Name of contact person	Keiko Nozawa
Organization	National Cancer Center Hospital
Division name	Appearance Support Center
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
TEL	03-3547-5201(3015)
Homepage URL
Email	knozawa@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital, Appearance Support Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017784