臨床研究等提出・公開システム

Japanese

Date of registration	July. 02, 2022
Last modified on	July. 02, 2022
Trial ID	jRCT1030220176

Scientific Title	Evaluation of long-term rehabilitation and nutritional management for tailored medicine after esophageal cancer surgery
Public Title	Nutritional management and rehabilitation after esophageal cancer surgery

Contact for Scientific Queries	Name	SATO HIROSHI
	Affiliation	Saitama Medical University International Medical Center
	Address	1397-1 Yamane, Hidakashi, Saitama
	Telephone	+81-42-984-4111
	E-mail	hsrevo0259@gmail.com
Contact for Public Queries	Name	Sato Hiroshi
	Affiliation	Saitama Medical University International Medical Center
	Address	1397-1 Yamane, Hidakashi, Saitama
	Telephone	+81-42-984-4111
	E-mail	hsrevo0259@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		July. 02, 2022
Target sample size		60
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) The primary lesion is located in the cervical, thoracic esophagus, or esophagogastric junction (UICC-TNM, 8th edition). 2) Histopathologically diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma. 3) The patient is scheduled to receive preoperative adjuvant therapy (chemotherapy, chemoradiotherapy) and radical open surgery (including specular surgery). 4) Written consent has been obtained from the patient. 5) Patient is 20 years of age or older and under 80 years of age. 6) Patient has a PS of 0 or 1. 7) Patients do not have active multiple cancers. 8) Patient has preserved organ function.
	Exclusion Criteria	1) Inability to give consent to participate in the study 2) Difficulty in making regular visits to the hospital
	Age Minimum	20age old exceed
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Esophageal Cancer
Intervention(s)		long-term rehabilitation and nutritional management
Health Condition(s) Keyword		Esophageal Cancer
Intervention(s) Keyword		nutrition, rehabilitation
Health Condition(s) Code		D004938
Intervention(s) Code		D012046
Primary Outcome(s)		Relationship between rehabilitation intervention results and improved nutritional assessment
Secondary Outcome(s)		1) Compliance rate with rehabilitation 2) Changes in nutritional indicators 3) Identification of groups in need of rehabilitation and nutrition intervention

Primary Sponsor	HIROSHI SATO

Secondary Sponsor

Source of Monetary Support	Grants-in-Aid for Scientific Research
Secondary Sponsor	Not applicable

Name of Certified Review Board	Saitama Medical School International Medical Center Clinical Research IRB
Address	Yamane 1397-1, Hidaka-shi, Saitama
Telephone	+81-42-984-4111
E-Mail	imc_irb@saitama-med.ac.jp
Approval Status	Approval
Date of approval	May. 18, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none