Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC)

Ninjinyoeito for hematotoxicity of adjuvant chemotherapy for breast cancer patients: a randomized controlled trial (NYTBC) - NYTBC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014827

Enrollment

Registered

2014-08-12

Start date

2014-02-20

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

Breast cancer

Interventions

Oral administration of Tsumura Ninjinyoeito extracted granules (for ethical use) 7.5 g/day (ref: http://kconsort.umin.jp). The intervention starts on day 1, and is continued until the end of the study

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pathologically-proven breast cancer 2. No prior chemotherapy 3. Adjuvant chemotherapy 4. PS is 1.

Exclusion criteria

Exclusion criteria: 1. Blood transfusion within 7 days of registration 2. Pleural effusion and ascites 3. Multiple cancers 4. Severe drug hypersensitivity 5. Active infection 6. Severe ECG abnormalities 7. Severe pulmonary diseases 8. Ploblematic psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Frequency of neutropenia greater than grade 3 on day 10 of each cycle of chemotherapy	—

Secondary

Measure	Time frame
1. Use of G-CSF during the total period of chemotherapy 2. Relative dose intensity 3. Completion rate of the regimen 4. Hemoglobin concentration on day 10 of each chemotherapy cycle 5. Platelet count on day 10 of each chemotherapy cycle	—

Countries

Japan

Contacts

Public ContactYoshiharu Motoo

Kanazawa Medical University Department of Medical Oncology

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

Outcome results

None listed

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