UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055155 |
|---|---|
| Receipt number | R000062956 |
| Scientific Title | The combined effect of Slow movement Training with tonic force generation and Aerobic exercise befoRe starting cancer Therapy for lung cancer patients |
| Date of disclosure of the study information | 2024/08/05 |
| Last modified on | 2025/02/04 14:42:34 |
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Basic information
Public title
The combined effect of Slow movement Training with tonic force generation and Aerobic exercise befoRe starting cancer Therapy for lung cancer patients
Acronym
The combined effect of Slow movement Training with tonic force generation and Aerobic exercise befoRe starting cancer Therapy for lung cancer patients
Scientific Title
The combined effect of Slow movement Training with tonic force generation and Aerobic exercise befoRe starting cancer Therapy for lung cancer patients
Scientific Title:Acronym
The combined effect of Slow movement Training with tonic force generation and Aerobic exercise befoRe starting cancer Therapy for lung cancer patients
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility and safety of active exercise therapy in patients with suspected advanced lung cancer scheduled for close examination and treatment during the period between the start of close examination for staging and pathological diagnosis and the start of anticancer drug treatment after a confirmed diagnosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lower extremity training for patients suspected of having advanced lung cancer and scheduled for close examination and initial chemotherapy, from the time of initial consultation until the start of treatment.
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
Patients who meet all of the following criteria are eligible
1 Patients who are 20 years of age or older at the time of consent
2 Patients with suspected lung cancer who have made an initial outpatient visit
3 Gender: any gender
4 Patients suspected of having advanced lung cancer at the time of initial consultation and scheduled for close examination and treatment
5 Patients who have been fully informed about their participation in this study, and who have given their free and voluntary consent based on their full understanding of the study.
Key exclusion criteria
Patients who fall into any of the following categories shall not be included in this study
1 Patients with severe hepatic or renal dysfunction
2 Pregnant or lactating women
3 Other patients deemed inappropriate as research subjects by the principal investigator
4 Patients with respiratory failure requiring oxygen inhalation or with severe pain that makes it difficult to assess physical function.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Utae |
| Middle name | |
| Last name | Katsushima |
Organization
Kansai Medical University
Division name
Department of Thoracic Oncology
Zip code
573-1191
Address
2-3-1Shin-machi Hirakata city, Osaka 573-1191,Japan
TEL
+81-072-804-0101
katsushu@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Utae |
| Middle name | |
| Last name | Katsushima |
Organization
Kansai Medical University
Division name
Department of Thoracic Oncology
Zip code
573-1191
Address
2-3-1Shin-machi Hirakata city, Osaka 573-1191,Japan
TEL
+81-072-804-0101
Homepage URL
katsushu@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Department of Thoracic Oncology
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Department of Thoracic Oncology
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 Medical University Hospital Research Ethics Review Committee
Address
2-5-1-701 Shin-machi Hirakata city,Osaka 573-1010
Tel
072-804-2440
rinriirb@hirakata.kmu.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
| 2024 | Year | 08 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062956
