UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044944 |
|---|---|
| Receipt number | R000051339 |
| Scientific Title | An observational study of changes in exercise capacity associated with long hospitalization in patients with lung, esophageal, and head and neck cancer undergoing radiotherapy and chemoradiotherapy -Pilot study- |
| Date of disclosure of the study information | 2021/07/23 |
| Last modified on | 2022/12/28 08:19:00 |
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Basic information
Public title
An observational study of changes in exercise capacity associated with long hospitalization in patients with lung, esophageal, and head and neck cancer undergoing radiotherapy and chemoradiotherapy -Pilot study-
Acronym
An observational study of changes in exercise capacity in patients undergoing hospitalized RT and CRT
Scientific Title
An observational study of changes in exercise capacity associated with long hospitalization in patients with lung, esophageal, and head and neck cancer undergoing radiotherapy and chemoradiotherapy -Pilot study-
Scientific Title:Acronym
An observational study of changes in exercise capacity in patients undergoing hospitalized RT and CRT
Region
| Japan |
Condition
Condition
Non-small cell lung cancer, esophageal cancer, head and neck cancer
Classification by specialty
| Medicine in general | Radiology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the proportion and characteristics of patients who decreased exercise capacity beyond minimal clinically important difference, in patients with lung, esophageal, and head and neck cancer who are scheduled for long hospitalization for radiotherapy and chemoradiotherapy.
Basic objectives2
Others
Basic objectives -Others
To explore the effects of long hospitalization treatment on motor function and characteristics of these changes, and to consider the appropriate timing and content of rehabilitation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion and characteristics of patients who decreased exercise capacity beyond minimal clinically important difference (a decrease of more than -40 m in the 6-minute walk test) between the start of irradiation and 4-8 weeks after the start of irradiation.
Key secondary outcomes
Relationship between exercise capacity and physical activity, sarcopenia, fatigue, cachexia, and quality of life, and these changes.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-small cell lung cancer (n=20)
Esophageal cancer (n=20)
Head and neck cancer (n=20)
1) they are scheduled for radical or semi-radical RT/CRT
2) They are scheduled to be hospitalized for at least 3 weeks from the start of irradiation.
3) Having written informed consent
4) Able to read and write Japanese
Key exclusion criteria
1) They are hospitalized only during chemotherapy
2) Stereotactic body radiation therapy is scheduled.
3) RT/CRT as adjuvant therapy before and after surgery
4) Diagnosis of unstable angina or myocardial infarction within 1 month prior to enrollment
5) Having bone metastases with limited exercise by doctor
6) Having psychosis or neurological symptoms that make it difficult to administer the questionnaire accurately
7) Determined by the doctor to be ineligible for enrollment in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Fuseya |
Organization
Shizuoka Cancer Center
Division name
Division of Rehabilitation Medicine
Zip code
411-8777
Address
1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
h.fuseya@scchr.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Unno |
Organization
Shizuoka Cancer Center
Division name
Division of Rehabilitation Medicine
Zip code
411-8777
Address
1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
mi.kitagawa@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
tansaku_office@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 23 | 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
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 07 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051339
