UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045479 |
|---|---|
| Receipt number | R000051921 |
| Scientific Title | A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Neoadjuvant Chemotherapy for Esophageal Cancer |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2022/09/20 19:26:48 |
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Basic information
Public title
A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Neoadjuvant Chemotherapy for Esophageal Cancer
Acronym
A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Neoadjuvant Chemotherapy for Esophageal Cancer
Scientific Title
A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Neoadjuvant Chemotherapy for Esophageal Cancer
Scientific Title:Acronym
RENUAL trial
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the participation rate of preoperative rehabilitation and nutritional interventions in preoperative chemotherapy patients with esophageal cancer, and to examine the feasibility of implementing these interventions in actual clinical practice.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participation rate in preoperative intervention programs
Key secondary outcomes
1.Rate of exercise therapy and dietary guidance
2.Perioperative complication rate
3.Perioperative respiratory complication rate
4.Postoperative hospital stay
5.Sarcopenia assessment
1)Grip strength
2)Short Physical Performance Battery (SPPB)
3)SWT(Shuttle Walking Test)
4)Muscle mass
6.Frailty assessment
7.Activity level
8.Functional screening assessment for the elderly
9.Oral hygiene/feeding status/swallowing function assessment
10.Speech function assessment
11.Nutrition assessment
12.QOL assessment
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutritional and rehabilitative interventions
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. Histologically diagnosed as squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or basal cell carcinoma on endoscopic biopsy of the primary esophageal lesion.
2. The main locus of the lesion (primary tumor, intraesophageal metastasis, or intraepithelial extension) is located within the thoracic esophageal cancer or at the esophagogastric junction.
3. Patients scheduled to receive preoperative chemotherapy for esophageal cancer.
4.Patients must be at least 20 years old on the date of enrollment.
5. Performance status (PS) of 0 or 1 according to ECOG criteria.
6.Patients must be eligible for open thoracotomy (or thoracoscopy or robot-assisted surgery) and open abdominal surgery (or laparoscopy or robot-assisted surgery) for radical esophageal cancer (R0).
7.The patient's written consent to participate in the study has been obtained.
Key exclusion criteria
1. Infectious disease requiring systemic treatment. (Because rehabilitation is difficult)
2. Patient has a fever of 38 degrees Celsius or higher. (Due to difficulty in rehabilitation)
Patient has poorly controlled diabetes mellitus (HbA1c of 6.5% or higher is the standard). (Due to difficulty in nutritional intervention)
4. Complicated psychosis or psychiatric symptoms, which will make it difficult to participate in the study. (Due to difficulty in rehabilitation)
5. Patient has poorly controlled hypertension. (Due to difficulty in rehabilitation)
6. Patient has unstable angina (angina pectoris with onset or worsening within the last 3 weeks) or myocardial infarction within the last 6 months. (Due to difficulty in rehabilitation)
7. Patient has interstitial pneumonia, pulmonary fibrosis, severe emphysema, or heart failure. (Due to difficulty in rehabilitation)
8. Patient has a history of cerebrovascular disease (cerebral infarction, intracerebral hemorrhage, transient ischemic attack, etc.) that occurred within 6 months. (Due to difficulty in rehabilitation)
9. Other patients who are deemed unsuitable for enrollment in this clinical trial by the physician in charge.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University Hospital
Division name
General and Digestive Surgery
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-5363-3802
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Tsuji |
Organization
Keio University Hospital
Division name
General and Digestive Surgery
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-5363-3802
Homepage URL
t.tsuji0504@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine, ethics committee
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
Tel
03-5363-3879
med-rinri-jimu@adst.keio.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
| 2021 | Year | 09 | Month | 24 | 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 | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | 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
| 2021 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051921
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| Registered date | File name |
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