Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058416) titled 'Evaluation of long-term rehabilitation and nutritional management
for tailored medicine after esophageal cancer surgery' on July 10.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Saiatama Medical University
Condition:
Condition - Thoracic esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To examine the temporal recovery from surgical trauma in patients undergoing surgery for esophageal cancer and to clarify the current effectiveness of outpatient rehabilitation and nutritional interventions, thereby identifying issues and determining the groups requiring active intervention and the appropriate intervention methods.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - This study aims to clarify how physical performance, body composition analysis, physical activity measured by a pedometer, nutritional intake, and nutritional indicators measured by blood tests change from the start of treatment to one year after surgery.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) The primary tumor is located in the neck, thoracic esophagus, or esophagogastric junction (UICC-TNM 8th edition).
2) Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or basaloid carcinoma.
3) Preoperative adjuvant therapy (chemotherapy, chemoradiotherapy) and curative thoracotomy or laparotomy (including laparoscopic surgery) are planned.
4) Written informed consent has been obtained from the patient.
5) Age 20 years or older and 80 years or younger.
6) Performance status (PS) is 0 or 1.
7) No active concurrent cancer.
8) Organ function is preserved.
Key exclusion criteria - 1) If consent to participate in the trial cannot be obtained
2) If regular hospital visits are difficult
Target Size - 60
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2022 Year 02 Month 25 Day
Date of IRB - 2022 Year 05 Month 18 Day
Anticipated trial start date - 2022 Year 05 Month 18 Day
Last follow-up date - 2024 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066791
Disclaimer: Curated by HT Syndication.