UMIN-CTR Clinical Trial

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
Email	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
Email	t.tsuji0504@gmail.com

Sponsor
Institute	Keio University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051921