UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040633
Receipt number 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 2023/12/05 10:22:19

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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

Japan


Condition

Condition

gastric cancer, esophageal cancer, biliary cancer, pancreatic cancer

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

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

a) Exercise therapy: 1) Exercise therapy completion rate, 2) Improvement rate of exercise assessment items, 3) Total number of steps per day during the period of exercise therapy
2-a) Improvement rate of walking speed (10m walk)
2-b) Improvement rate of grip strength
2-c) Improvement value of the Simplified Physical Performance Battery (SPPB)
2-d) Improvement value of Timed-up-and-go test (TUG)
2-e) Improvement value of SARC-F Japanese version questionnaire

b) Nutritional therapy: 1) Completion rate of nutritional supplements, 2) Average amount of food consumed, 3) Improvement rate of nutritional status assessment items
3-a) Improvement value of MNA-SF
3-b) Improvement rate of upper arm circumference
3-c) Improvement rate of upper arm muscle circumference
3-d) Improvement rate of triceps subcutaneous fat thickness
3-e) Improvement value of CONUT
3-f) Improvement value of PNI
3-g) Improvement value of GNRI
c) Chemo(radiation) therapy-related side effects
d) Perioperative complications
e) Tumor reduction (evaluated by Evans classification)
f) Postoperative adjuvant chemotherapy: Rate of postoperative adjuvant chemotherapy, days from surgery to first chemotherapy administration


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


Not applicable

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.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kimitaka
Middle name
Last name Tanaka

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

Email

kimitaka.t@gmail.com


Public contact

Name of contact person

1st name Kimitaka
Middle name
Last name Tanaka

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


Email

kimitaka.t@gmail.com


Sponsor or person

Institute

Hokkaido University hospital

Institute

Department

Personal name



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

Hokkaido University Hospital institutional review board

Address

Kita-ku North 14 West 5, Sapporo, Hokkaido, Japan

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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 06 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

30

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

No longer recruiting

Date of protocol fixation

2020 Year 03 Month 06 Day

Date of IRB

2020 Year 03 Month 23 Day

Anticipated trial start date

2020 Year 06 Month 20 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing special


Management information

Registered date

2020 Year 06 Month 02 Day

Last modified on

2023 Year 12 Month 05 Day



Link to view the page

Value
https://center6.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