Randomized controlled trial of the efficacy of supportive care during adjuvant chemotherapy

JRCT ID: jRCTs051210007

Registered date:15/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 07/07/2021
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Take one packet of Supersynbiotics LBG-P twice a day from 7 days or more before the start of adjuvant chemotherapy to 6 months after the start of adjuvant chemotherapy.

Outcome(s)

• Primary Outcome: Rate of patients without dose reduction of S1 or with one-level dose reduction of S1 for one one year
• Secondary Outcome: Actual total prescription dose / planned total dose ratio of S1 or Docetaxel; adverse events of chemotherapy; QOL; body composition; muscle strength; nutritional parameter; intestinal environment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Patients with primary gastric cancer between the ages of 20 and 80 who underwent curative gastr
ectomy and scheduled to receive adjuvant chemotherapy with S1 or S1 plus docetaxel
2. PS(ECOG) 0-1
3. White blood cells > lower limit of normal (LLN) or 4000/mm3 and < 12000/mm3
4.Neutrophils >1500/mm3
5.Hemoglobin>8.0g/dL
6.Aspartate aminotransferase (glutamic-oxaloacetic transaminase) (AST(GOT)) and alanine aminotransferase (glutamic-pyruvic transaminase) (ALT(GPT)) <3.0 x upper limit of normal (ULN) of the study site
7.Total bilirubin <1.5mg/dL
8.Creatinine <1.2mg/dL
9.Creatinine clearance>60 mL/min

Exclude criteria

1. Patients with a history of intestinal resection other than gastrectomy, hepatectomy, or pancreatic resection
2. Patients with simultaneous or metachronous cancer
3. Patients with serious postoperative complications
4. Patients with serious comorbidities, such as interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, heart failure, renal failure, and liver cirrhosis
5. Patients receiving systemic administration of steroids
6. Patients taking flucytosine
7. Patients taking warfarin potassium

Related Information

• Primary Sponsor: Motoori Masaaki
• Source(s) of Monetary Support: osaka foundation for the prevention of cancer and cardiovascular diseases