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Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer

Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer - Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019664
Enrollment
50
Registered
2015-11-06
Start date
2015-11-16
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 Hangeshashinto 7.5g/day t.i.d. before meals or between meals. No take Hangeshashinto.

Sponsors

Osaka Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with breast cancer who wndergo chemotherapy 2. Patients with oral mucositis caused by prior chemotherapy 3. ECOG Performance status:0-1 4. Over 20 years old female 5. Patients who maintain main organs function 1 White blood cells count >2,500/mm3 2 Neutrophil count >1,500/mm3 3 Platelet count > 10.0*10^4/mm3 4 AST,ALT> normal limit * 2.5 5 Serum total bilirubin< normal limit X 1.5 6 Serum creatinine < normal limit 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who receives a medical prescription of herbal medicine within 2 weeks before registration of the final examination 2. Patients with the past of severe medicine hyperesthesia or severe drug allergy 3. Anti-inflammation anodyne medicine, OPIOIDO or the patient who has a medical treatment by a steroid 4.Sense unusualness or perception, some incomplete patients 5. Patients with active double cancer 6. Patients with serious heart diseases 7. Patients with serious lung diseases 8. Patients with serious constipation 9. Pregnant woman, lactating woman and patient with a possibility of the pregnancy

Design outcomes

Primary

MeasureTime frame
DTM:Duration time of oral mucositis for 21 days

Secondary

MeasureTime frame
Incidence of oral mucostis, Incidence of diarrhea, Blood level of CRP, Change of body weight and blood level of albumin

Countries

Japan

Contacts

Public ContactMitsuhiko Iwamoto

Osaka Medical College Hospital Department of Breast Surgery

sur067@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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