UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028801
Receipt number R000032961
Scientific Title A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Date of disclosure of the study information 2017/09/01
Last modified on 2023/02/25 10:01:41

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Basic information

Public title

A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer

Acronym

NEXTAC-TWO study

Scientific Title

A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer

Scientific Title:Acronym

NEXTAC-TWO study

Region

Japan


Condition

Condition

Non-small-cell lung and pancreatic cancer

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To extend disability-free survival in elderly patients with advanced non-small cell and pancreatic cancer by early induction of multimodal care with nutritional and exercise intervention

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Disability-free survival

Key secondary outcomes

1. lean body mass
2. physical function
3. nutritional status
4. quality of life
5. safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Other

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) >=70 years old and ECOG-PS 0-2
2) newly diagnosed NSCLC/pancreatic cancer in stage III, IV, or post-operative recurrence.
3) They are planned to receive the first-line systemic chemotherapy
4) Having written informed consent
5) More than 3 months of survival was expected

Key exclusion criteria

1) Having disabilities according to the modified KATZ index
2) Having high risks for safe physical assessments and interventions (e.g. Unstable cardiac diseases, Severely symptomatic brain or bone mets, severe phyciatric disease, etc)
3) Having difficulties in swallowing, digesting, and absorbing food

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Takayama

Organization

Kyoto Prefectual University of Medicine

Division name

Department of Respirology

Zip code

602-8566

Address

Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN

TEL

075-251-5513

Email

takayama@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Tateaki
Middle name
Last name Naito

Organization

Shizuoka Cancer Center

Division name

Division of thoracic oncology

Zip code

411-8777

Address

1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

055-989-5222

Homepage URL


Email

t.naito@scchr.jp


Sponsor or person

Institute

Department of Respirology, Kyoto Prefectual University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka Cancer Center Institutional Review Board

Address

1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

Tel

0559895222

Email

t.naito@scchr.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

京都府立医科大学大学(京都府)、静岡県立静岡がんセンター(静岡県)、新潟県立がんセンター(新潟県)、国立がん研究センター東病院(千葉県)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 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

131

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

under review

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

2017 Year 08 Month 22 Day

Date of IRB

2017 Year 08 Month 22 Day

Anticipated trial start date

2017 Year 11 Month 06 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 23 Day

Last modified on

2023 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032961


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name