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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030124
Receipt No. R000034394
Scientific Title A phase II study about the efficacy of an intervention of excercise therapy on the adjuvant chemotherapy for pancreatic cancer: Exercise-PC Study
Date of disclosure of the study information 2017/11/26
Last modified on 2019/05/29

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Basic information
Public title A phase II study about the efficacy of an intervention of excercise therapy on the adjuvant chemotherapy for pancreatic cancer: Exercise-PC Study
Acronym Exercise impact on adjuvant chemotherapy for pancreatic cancer
Scientific Title A phase II study about the efficacy of an intervention of excercise therapy on the adjuvant chemotherapy for pancreatic cancer: Exercise-PC Study
Scientific Title:Acronym Exercise impact on adjuvant chemotherapy for pancreatic cancer
Region
Japan

Condition
Condition Invasive ductal adenocarcinoma of pancreas
Classification by specialty
Hepato-biliary-pancreatic surgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the efficacy of an S-1 adjuvant chemotherapy combined with a supervised exercise program for pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The completion rate of four courses of S-1 adjyvant chemotherapy.
Key secondary outcomes 1. Relative dose intensity of S-1: Until 6 months after the first day of adjuvant therapy
2. Recurrence free survival time
3. Overall survival time
4. Safety of the protocol therapy of this study: Until 6 months after the first day of adjuvant therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise Therapy:
[Peoperative]
1.Squat,Heel raise,Gluteus medius muscle training 60min
2.Exercise bile 60-70%HRR 30min
3.Hand ergo 60-70%HRR 20min
4.Stepping the stairs
5.Voluntary training
[Postoperative]
POD1-5: Corridor walking
POD5-7: Mild to moderate squat, Stepping the stairs
POD7-: Exercise bike, Hand ergo
Goalof discharge: 70% of body power on admission
[After discharge]
Exercise outpatient clinic:
3days/week
1. Squat,Heel raise,Gluteus medius muscle training 60min
2. Exercise bike
3. Hand ergo
4. Stepping the stairs
5. Voluntary training

Six min walk test on admission and discharge, and aerobic exercise was programmed based on CPX (Cardiopulmonary Exercise Training) on discharge.
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 1. Patients with resected pancreatic cancer that was a histologically verified invasive ducal carcinoma of the pancreas (StageI/II or stage III combined resected with artery based on UICC ver.8).
2. Local residual tumor classified as R0 or R1.
3. Cytologic examination negative upon intraoperative peritoneal lavage
4. Until 10 weeks after surgery
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
6. Age of 20 years or above
7. Written informed consent given
Key exclusion criteria 1. Severe drug hypersensitivity or drug allergy
2. Multiple primary cancers within 5 years.
3. Severe infection
4. With watery diarrhea
5. Interstitial pneumonia or pulmonary fibrosis
6. With uncontrollable pleural effusion or ascites
7. With uncontrollable diabetes mellitus
8. With severe heart failure, angina, hypertension, arrhythmia
9. Walking akinesia
10. With severe malnutrition
11. With severe neurological/psychological symptoms
12. Pregnant or lactating women or women with unknown or suspected pregnancy
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Ken-ichi
Middle name
Last name Okada
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address Kimiidera 811-1, Wakayama City
TEL 073-441-0613
Email okada@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Ken-ichi
Middle name
Last name Okada
Organization Wakayama Medical University
Division name Second Department of surgery
Zip code 641-8510
Address Kimiidera 811-1, Wakayama City
TEL 073-441-0613
Homepage URL
Email okada@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization None
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 Institutional Review Board of Wakayama Medical University
Address Kimiidera 811-1, Wakayama City
Tel 073-447-2300
Email warinri@wakayama-med.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
2017 Year 11 Month 26 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 23 Day
Date of IRB
2017 Year 12 Month 05 Day
Anticipated trial start date
2017 Year 12 Month 05 Day
Last follow-up date
2020 Year 11 Month 30 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 11 Month 26 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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