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

Randomized controlled trial of the efficacy of supportive care during adjuvant chemotherapy in patients with gastric cancer - ACCORD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051210007
Enrollment
150
Registered
2021-04-15
Start date
2021-07-07
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer gastric cancer

Interventions

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.

Sponsors

Motoori Masaaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 1500/mm3 5.Hemoglobin>8.0g/dL 6.Aspartate aminotransferase (glutamic-oxaloacetic transaminase) (AST(GOT)) and alanine aminotransferase (glutamic-pyruvic transaminase) (ALT(GPT)) 60 mL/min

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Rate of patients without dose reduction of S1 or with one-level dose reduction of S1 for one one year

Secondary

MeasureTime frame
Actual total prescription dose / planned total dose ratio of S1 or Docetaxel; Rate of patients without dose reduction of S1 or with one-level dose reduction of S1 for six months; adverse events of chemotherapy; QOL; body composition; muscle strength; nutritional parameter; intestinal environment

Contacts

Public ContactMasaaki Motoori

Osaka General Medical Center

motoorim@gh2.opho.jp+81-6-6692-1201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026