UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051806 |
|---|---|
| Receipt number | R000058843 |
| Scientific Title | Multicenter randomized Trial of expIratory traininG for Esophageal canceR patientS undergoing neoadjuvant therapy |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2025/02/04 19:28:30 |
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Basic information
Public title
Multicenter randomized Trial of expiratory training for Esophageal cancer patients undergoing neoadjuvant therapy
Acronym
Tigers trial
Scientific Title
Multicenter randomized Trial of expIratory traininG for Esophageal canceR patientS undergoing neoadjuvant therapy
Scientific Title:Acronym
Tigers trial
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether changes in tongue pressure caused by exhalation training with balloons can reduce postoperative pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tongue pressure changes before and after chemotherapy
Key secondary outcomes
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
| Other |
Interventions/Control_1
Subjects will be 100 patients (intervention group: 50 patients, non-intervention group: 50 patients) scheduled for preoperative chemotherapy and radical resection for resectable advanced esophageal cancer, and will be randomly assigned.In the intervention group, during the preoperative chemotherapy period, in addition to the usual medical care, training is performed using expiratory training.
Interventions/Control_2
In the non-intervention group, the patient is treated as usual.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients with resectable advanced esophageal cancer (Stage II-IVA (12th edition of the Esophageal Cancer Treatment Protocol)) who are scheduled to undergo preoperative chemotherapy followed by subtotal esophagectomy and gastric tube reconstruction.
(2) Patients who are 18 years of age or older on the date of enrollment.
(3) Patients who can obtain written consent to participate in this study
(4) Patients who are able to perform exhalation training with a balloon.
Key exclusion criteria
(1) Cases in which physical training is considered difficult to perform
(2) Patients with difficulty in oral intake (nasal feeding tube inserted, dysphagia score 4)
(3) Cases of combined pharyngolaryngectomy
(4) Preoperative chemoradiotherapy cases
(5) Patients with latex allergy
(6) Other patients deemed inappropriate for the study by the physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yamasaki |
Organization
Kasai Medical University
Division name
Department of Upper Gastrointestinal Surgery
Zip code
573-1010
Address
2-5-1,Shinmachi, Hirakata, Osaka 573-1010, JAPAN
TEL
072-804-0101
yamasakm@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Yamamomo |
Organization
Kasai Medical University
Division name
Department of Upper Gastrointestinal Surgery
Zip code
573-1010
Address
2-5-1,Shinmachi, Hirakata, Osaka 573-1010, JAPAN
TEL
072-804-0101
Homepage URL
yamanobu@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kasai Medical University
Institute
Department
Personal name
Funding Source
Organization
Katanokai
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
Kasai Medical University
Address
2-5-1,Shinmachi, Hirakata, Osaka 573-1010, JAPAN
Tel
072-804-0101
yamanobu@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
| 2023 | Year | 08 | Month | 08 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 08 | Month | 02 | 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=R000058843
