UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of skin data of hyperpigmentation caused by chemotherapy with pyrimidine fluoride-derived anticancer agent for development of a medical cover foundation
Title of the study (Brief title)	Measurement of skin data of hyperpigmentation caused by chemotherapy with pyrimidine fluoride-derived anticancer agent
Region	Japan

Condition
Condition	gastric cancer, colorectal cancer and esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to measure optical properties of hyperpigmentation caused by chemotherapy with pyrimidine fluoride-derived anticancer agent for development of a medical cover foundation.
Basic objectives2	Others
Basic objectives -Others	To reveal characteristics of optical properties of hyperpigmentation for patients who have strong hyperpigmentation and feel a mental painfulness or distress.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	<Assessment by devices> 1) Optical properties (absorption and scattering coefficients) 2) Spectral reflectivity 3) Visia (Facial skin condition) 4) Epidermal and dermal water content <Self-completed questionnaires> Appearance-related distress
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients who have received pyrimidine fluoride-derived anticancer agent (S-1, capecitabine or 5-FU) more than one month. 2) Patients who have grade 2 "skin hyperpigmentation" in CTCAE Version 4.0. 3) PS of 0 or 1. 4) Written informed consent.
Key exclusion criteria	1) Patients who are unable to respond to self-completed questionnaires. 2) Patients who are judged inappropriate for participate in this study by physician.
Target sample size	30

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	Japanese Governmental office
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	2016 Year 06 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 18 Day
Anticipated trial start date	2016 Year 06 Month 09 Day
Last follow-up date
Date of closure to data entry	2016 Year 10 Month 18 Day
Date trial data considered complete	2016 Year 10 Month 18 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is to measure optical properties of hyperpigmentation caused by chemotherapy with pyrimidine fluoride-derived anticancer agent.

Management information
Registered date	2016 Year 06 Month 15 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=R000026206