UMIN-CTR Clinical Trial

Basic information
Public title	Factors affecting nutritional status of esophageal cancer patients who received chemoradiotherapy after discharge
Acronym	Factors affecting nutritional status of esophageal cancer patients after discharge
Scientific Title	Factors affecting nutritional status of esophageal cancer patients who received chemoradiotherapy after discharge
Scientific Title:Acronym	Factors affecting nutritional status of esophageal cancer patients after discharge
Region	Japan

Condition
Condition	thoracic esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the factors affecting the nutritional status of esophageal cancer patients who received chemoradiotherapy from hospitalization to 6 months after discharge.
Basic objectives2	Others
Basic objectives -Others	Exploring related factors
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Factors affecting the nutritional status
Key secondary outcomes	Changes in nutritional status from admission to 6 months after discharge

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients with primary thoracic esophageal cancer (2) Age 20 years or older, 90 years or younger at the time of irradiation (3) Those who were admitted to the Tohoku University Hospital West 4th floor ward for the treatment of the above diseases (4) Those who received chemoradiation at our hospital from April 2019 to March 2020
Key exclusion criteria	(1) Head and neck cancer (2) After surgical resection (3) There is a history of irradiation to the same part in the past
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yumi Middle name Last name Shoji
Organization	Tohoku University Hospital
Division name	Outpatient I
Zip code	980-8575
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7732
Email	yoko.takeishi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Takeishi
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Women's Health Nursing & Midwifery
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7933
Homepage URL
Email	yoko.takeishi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	MHLW Certified Clinical Research Review Board, Tohoku University
Address	2-2-1 Katahira, Aoba-ku, Sendai, Miyagi
Tel	022-718-0461
Email	office@nurs.hosp.tohoku.ac.jp

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	2020 Year 05 Month 03 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	Preinitiation
Date of protocol fixation	2020 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 30 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study Study 1: Medical record survey, opt-out survey, extract eligible person from irradiation history, and collect necessary data from medical record Study 2: Follow-up survey, eligible outpatient visitor receive questionnaire survey (face-to-face survey) by a researcher working the outpatient after informed consent

Management information
Registered date	2020 Year 05 Month 03 Day
Last modified on	2020 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045949

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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