Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2)

Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2) - HOPE-2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012745

Enrollment

Registered

2014-01-06

Start date

2014-01-06

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

Colorectal cancers

Interventions

Oral administraion of Tsumura ninjinyoeito extracted granule (for ethical use) Non-administraion of Tsumura ninjinyoeito extracted granule (for ethical use)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically-proven colorectal cancers 2. Pathologically-proven stage IIIa or IIIb 3. Curative A resected 4. No history of chemotherapy, immunotherapy, or radiotherapy for pain control 5. More than 2 weeks after operation 6. PS 0-1 7. No severe dysfunction in major organs 8. Oral intake is possible

Exclusion criteria

Exclusion criteria: 1. Blood transfusion or G-CSF administration within 7 days 2. Pleural effusion, ascites, or pericardial effusion, necessary for drainage 3. double cancers 4. drug hypersensitivity 5. diabetic neuropathy 6. diabetes mellitus, necessary for insulin therapy

Design outcomes

Primary

Measure	Time frame
peripheral neuropathy	—

Secondary

Measure	Time frame
hemoglobin concentration neutrophil count platelet count	—

Countries

Japan

Contacts

Public ContactYoshiharu Motoo

Kanazawa Medical University Department of Medical Oncology

motoo@kanazawa-med.ac.jp076-286-2211

Outcome results

None listed

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