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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040633 |
Receipt No. | R000046377 |
Scientific Title | The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy |
Date of disclosure of the study information | 2020/06/03 |
Last modified on | 2020/06/02 |
Basic information | ||
Public title | The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy | |
Acronym | The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy | |
Scientific Title | The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy | |
Scientific Title:Acronym | The evaluation of prehabilitation and nutritional support in cancer patients with neoadjuvant therapy | |
Region |
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Condition | |||
Condition | gastric cancer, esophageal cancer, biliary cancer, pancreatic cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose is to investigate the possibility of improving surgical outcomes and preventing sarcopenia by using prehabilitation and nutritional support during neoadjuvant therapy. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The change of 6 minutes walk test between before and after neoadjuvant therapy |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The patient with cancer(stomach, esophagus, biliary tract, pancreas) who was planned for neoadjuvant therapy. | |||
Key exclusion criteria | The patient with low ADL who have difficulty in exercising
The patient with dementia The patient who may get worse comorbidities or primary diseases by performing exercise therapy. The patient with severe diabetes The patient with gastrointestinal obstruction The patient who are not scheduled for surgery The patient who was judged by the researcher to be inappropriate for this research. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido university hospital | ||||||
Division name | Department of gastroenterological surgery 2 | ||||||
Zip code | 060-8638 | ||||||
Address | Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan | ||||||
TEL | 011-706-7714 | ||||||
kimitaka.t@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido university hospital | ||||||
Division name | Department of gastroenterological surgery 2 | ||||||
Zip code | 060-8638 | ||||||
Address | Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan | ||||||
TEL | 011-706-7714 | ||||||
Homepage URL | |||||||
kimitaka.t@gmail.com |
Sponsor | |
Institute | Hokkaido University hospital |
Institute | |
Department |
Funding Source | |
Organization | Department of gastroenterological surgery 2, Hokkaido University Faculty of Medicine. |
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 | Department of gastroenterological surgery 2, Hokkaido univeristy hospital |
Address | Kita-ku North 15 West 7, Sapporo, Hokkaido, Japan |
Tel | 011-706-7714 |
kimitaka.t@gmail.com |
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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Nothing special |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046377 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |