Quality of life for patients with patients with Esophago-gastric cancer receiving neo adjuvant chemotherapy followed by Surgery by TJ-48 (Juzentaihoto)

JRCT ID: jRCTs071200105

Registered date:02/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer/Gastric Cancer
• Date of first enrollment: 19/04/2021
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Cases assigned to the protocol treatment group will start oral administration of Juzentaihoto the evening before the chemotherapy. The oral administration will continue unless there are unacceptable adverse events. The cases assigned to the control group, there will be no placebo.

Outcome(s)

• Primary Outcome: Comprehensive QOL

Secondary Outcome

Itemized QOL
Adverse events
Nutrition evaluation index; PNI, CONUT(CONtrolling NUTritional status)
Skeletal muscle mass: By the CT scan and MRI
Inflammation markers

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.The age at the time of obtaining consent is 20 years old or older.
2.Written consent has been obtained from the patient to be a research subject for this protocol treatment.
3.The institutional research director decided that this protocol can be used for treatment or the registration is appropriate.
4.Histologically confirmed to be an esophageal cancer; squamous cell carcinoma, adenosquamous carcinoma, basal cell carcinoma or adenocarcinoma, or a gastric cancer; one of the general types of histological classification.
5.The clinical stage is cstage II or III according to the TNM classification.
6.Preoperative chemotherapy has been judged clinically appropriate and has been decided.
7.No history of surgical treatment for esophageal cancer or gastric cancer. However, endoscopic treatment is eligible.
8.No history of chemotherapy, radiation therapy or endocrine therapy for esophageal cancer and gastric cancer.
9.Have one or more complaints of "loss of appetite", "malaise" and "weakness".
10.Radical surgery (R0) is judged to be possible by the esophagectomy or gastrectomy.
11.The performance status (PS) is either 0 or 1 by the ECOG scale.
12.Laboratory test done within 14 days prior to the registration meet the following criteria. For the laboratory test, blood transfusion or administrating the hematopoietic factor preparations cannot be done within 14 days before the test date.
Neutrophil counts >= 1,500/uL
Platelets>= 100,000 /uL
Hemoglobin >= 10.0 g/dL
Total bilirubin <= 1.5 mg/dL
AST<= 100 IU/L
ALT<= 100 IU/L
Serum creatinine <= 1.5 mg/dL
Creatinine clearance >= 40 mL/min

Exclude criteria

Exclusion Criteria1.Received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 14 days before the registration.
2.Has severe drug hypersensitivity
3.Has an active infection; have a fever of 38.0 degrees Celsius or higher and bacterial infection has been confirmed by a diagnostic imaging or bacterial examinations. Local infections that do not affect general conditions will be excluded.
4.Esophageal cancer cases requiring combined laryngectomy
5.Has uncontrolled hypertension or diabetes. (Diabetes controlled by insulin injection is eligible.)
6.The 12-lead ECG shows significant abnormalities or has clinically relevant heart disease within 28 days prior to registration.
7.Has intestinal pneumonia, pulmonary fibrosis, severe emphysema etc. by diagnostic imaging such as CT scan.
8.Has a history of autoimmune disease or chronic and/or recurrent autoimmune diseases. (Cases with type I diabetes, hypothyroidism that can be treated with hormone replacement therapy, and skin diseases that do not require systemic treatment are eligible.)
9.Needs an administration of systemic corticosteroids and immunosuppressants. (Excludes prophylactic administration or temporary use for tests or allergic reactions.)
10.Cases taking herbal medicine. (If the administration of the herbal medicine have finished 4 weeks before the registration, it is acceptable.)
11.Has psychosis or psychiatric symptoms that it is difficult to participate.
12.Has fresh bleeding from the gastrointestinal tract that requires repeated blood transfusions.
13.Has a history of myocardial infarction or unstable angina within 6 months of registration.
14.Has CTCAE Grade 2 or higher diarrhea or chronic watery stools.
15.Has active double cancer. (Cases with a history of other cancers that have not recurred for more than 5 years is eligible.)
16.Pregnant or lactating women or women who may be pregnant, and men who wish that his partner to be pregnant.
17.HBs antigen positive, HCV antibody positive or HIV antibody positive. (Test for HIV is not necessary.)
18.The cases that principal investigator or the physician in charge judged to be inappropriate for this study.

Related Information

• Primary Sponsor: Kobayashi Kazuma
• Source(s) of Monetary Support: TSUMURA CO.,LTD.