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

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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)

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name