UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036771
Receipt number R000041895
Scientific Title A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy
Date of disclosure of the study information 2019/05/16
Last modified on 2021/12/31 09:50:49

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Basic information

Public title

A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy

Acronym

A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy

Scientific Title

A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy

Scientific Title:Acronym

A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy

Region

Japan


Condition

Condition

advanced or recurrenced lung and pancreatic cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Explore the efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

SPPB(Short Physical Performance Battery)

Key secondary outcomes

one leg standinf time
incidence rate of sarcopenia
lean body mass
physical function
nutritional status
quality of life
survival
safety
toxicity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

1. nutritional couseling
2. home-based exercise intervention
3. physical activity intervention

Interventions/Control_2

usual care

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

1) newly diagnosed LC/pancreatic cancer in stage III, IV, or post-operative recurrence.
2) >=20 years old
3) They are planned to receive the first-line systemic chemotherapy
4) Having written informed consent
5) full count of mKatz index

Key exclusion criteria

1) Having high risks for safe physical assessments and interventions (e.g. Unstable cardiac diseases, Severely symptomatic brain or bone mets, severe phyciatric disease, etc)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kusaba
Middle name
Last name Masahiko

Organization

Kansai Electric Power Hospital

Division name

Department of rehabilitation

Zip code

553-0003

Address

2-1-7Fukushima,Fukushima-ku,Osaka

TEL

0664585821

Email

masahiko-kusaba@hotmail.co.jp


Public contact

Name of contact person

1st name Kusaba
Middle name
Last name Masahiko

Organization

Kansai Electric Power Hospital

Division name

Department of rehabilitation

Zip code

553-0003

Address

2-1-7Fukushima,Fukushima-ku,Osaka

TEL

0664585821

Homepage URL


Email

masahiko-kusaba@hotmail.co.jp


Sponsor or person

Institute

Kansai Electric Power Hospital

Institute

Department

Personal name



Funding Source

Organization

Kansai Electric Power Hospital

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

Kansai Electric Power Hospital

Address

2-1-7Fukushima,Fukushima-ku,Osaka

Tel

0664585821

Email

masahiko-kusaba@hotmail.co.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

関西電力病院(大阪府)


Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 16 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

2019 Year 05 Month 10 Day

Date of IRB

2019 Year 05 Month 10 Day

Anticipated trial start date

2019 Year 05 Month 16 Day

Last follow-up date

2021 Year 12 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 05 Month 16 Day

Last modified on

2021 Year 12 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041895


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name