Unique ID issued by UMIN | UMIN000033895 |
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Receipt number | R000038659 |
Scientific Title | A phase II study to evaluate the oral nutrition supplementation for patients undergoing neoadjuvant chemotherapy for esophageal cancer |
Date of disclosure of the study information | 2018/10/01 |
Last modified on | 2021/02/25 20:37:21 |
A phase II study to evaluate the oral nutrition supplementation for patients undergoing neoadjuvant chemotherapy for esophageal cancer
ONS during NAC for esophageal cancer
A phase II study to evaluate the oral nutrition supplementation for patients undergoing neoadjuvant chemotherapy for esophageal cancer
ONS during NAC for esophageal cancer
Japan |
Esophageal cancer
Gastrointestinal surgery |
Malignancy
NO
To examine the efficacy of oral nutrition supplementation for patients undergoing neoadjuvant chemotherapy for esophageal cancer
Efficacy
Exploratory
Pragmatic
Phase II
Change rate of CONUT score
1) Change rate of QOL score, 2) Change rate of body weight, 3) Incidence of an adverse event (associated with oral nutrition supplementation), 4) Complete rate of neoadjuvant chemotherapy, 5) Incidence of postoperative complication, 6) Adherence rate of protocol treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Oral nutrition supplementation (at least 600 kcal / day or more) is continued up to the previous operation day for patients undergoing neoadjuvant chemotherapy for esophageal cancer.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) clinical stage IB, II or III (TNM 8th), 4) R0 resection with thoracoabdominal surgery, 5) adequate oral intake (Ogilvie's dysphagia score 0 or 1), 6) >20 and <80 y.o., 7) ECOG-PS 0 or 1, 8) No history of surgery for esophageal cancer, 9 ) No history of chemotherapy or radiotherapy, 10) a) WBC >2000 and <10000/mm3, b) PLT >50000/mm3, c) AST <100 IU/L, ALT <100IU/L, d) T-Bil <2.0 g/dl, e) Cre <1.5mg/dl, 11) Written consent
1) BMI <17.0 or >30.0, 2) Excision of other organs excluding stomach or gall bladder, 3) Active double cancer, 4) Pregnancy or breast-feeding, 5) Psychosis or mental symptoms, 6) Systemic administration of steroids, 7) History of myocardial infarction or unstable angina, 8) Poorly controlled hypertension, 9) Poorly controlled diabetes, 10) Respiratory disease requiring sustained oxygen therapy
85
1st name | Takashi |
Middle name | |
Last name | Kamei |
Tohoku University Hospital
Department of Surgery
980-8574
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
022-717-7214
tkamei@med.tohoku.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Okamoto |
Tohoku University Hospital
Department of Surgery
980-8574
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
022-717-7214
hi_ok_0531@yahoo.co.jp
Tohoku University Hospital
University grants of Tohoku University Hospital
Self funding
IRB of Tohoku University School of Medicine
2-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
NO
東北大学病院(宮城県)
2018 | Year | 10 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 09 | Month | 18 | Day |
2018 | Year | 09 | Month | 18 | Day |
2018 | Year | 10 | Month | 01 | Day |
2022 | Year | 02 | Month | 28 | Day |
2018 | Year | 08 | Month | 25 | Day |
2021 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038659
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