UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040300 |
|---|---|
| Receipt number | R000045949 |
| Scientific Title | Factors affecting nutritional status of esophageal cancer patients who received chemoradiotherapy after discharge |
| Date of disclosure of the study information | 2020/05/03 |
| Last modified on | 2021/11/03 12:27:32 |
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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
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
yoko.takeishi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
58
Results
CONUT value: The values at 1, 3 and 6 months after discharge were significantly lower than before discharge.
BMI: No significant difference
Symptoms after discharge: Swallowing pain, sickness, and malaise at the time of discharge, but alleviated or disappeared until 3 months after discharge.
Family acceptance: Some wives of patients said they thought patients would be able to eat regular meals immediately after discharge, but that was actually not so.
Results date posted
| 2021 | Year | 11 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age of subjects: 70.4 (SD 8.0) years
52 men (89.7%)
All Stages 1-4 included
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 25 | Day |
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
| 2021 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045949
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
