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Randomized study of comparing propylactic antibiotics with enteral nutrition and synbiotics for reducing adverse events during neoadjuvant chemotherapy in patients with esophageal cancer

Randomized study of comparing propylactic antibiotics with enteral nutrition and synbiotics for reducing adverse events during neoadjuvant chemotherapy in patients with esophageal cancer - Comparing propylactic antibiotics with enteral nutrition and synbiotics during neoadjuvant chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025557
Enrollment
80
Registered
2017-01-06
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Esophageal cancer

Interventions

Levofloxacin RACOL-NF Yakult BL Seichoyaku galactoorigosaccharides

Sponsors

Osaka Medical Center for Cancer and Cardiovascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically confirmed primary esophageal cancer, who are scheduled to receive neoadjuvant chemotherapy 2. Performance status is 0-1 3. Dysphagia score is 0-2 4. No serious abnormality in heart, lung, bone marrow, liver, and renal functions

Exclusion criteria

Exclusion criteria: 1. Synchronous or metachronous (within 5 years) malignancy 2. Uncontrolleddiabetes mellitus

Design outcomes

Primary

MeasureTime frame
Incidence of febrile neutropenia

Secondary

MeasureTime frame
Incidence of adverse events, fecal microbiota, fecal organic acid concentration, postoperative complications

Countries

Japan

Contacts

Public ContactKeijiro Sugimura

Osaka Medical Center for Cancer and Cardiovascular Diseases Surgery

sugimura-ke@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026