Preventive effect of Hangeshashin-to against oral mucositis in allogeneic hematopoietic stem cell transplantation

Preventive effect of Hangeshashin-to against oral mucositis in allogeneic hematopoietic stem cell transplantation - Hangeshashin-to for oral mucositis in allogeneic HSCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011015

Enrollment

Registered

2013-12-01

Start date

2013-06-01

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

Patients who receive their first allogeneic hematopoietic stem cell transplantation

Interventions

Hangeshashin-to 2.5g t.i.d., from the start of conditioning regimen to engraftment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who receive their first allogeneic HSCT 2)Use of methotrexate for prophylaxis of GVHD 3)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients who are not eligible for HSCT 2)Allergy to Hangeshashin-to 3)Patients who cannot take medicine orally, or have grade 2 or more oral mucositis at the start of conditioning regimen 4)Aldosteronism 5)Myopathy 6)Uncontrollable hypokalemia (<3.5 mEq/L) 7)Inadequate condition as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of grade 2 or more oral mucositis between the start of conditioning regimen and engraftment	—

Secondary

Measure	Time frame
1)Incidence and severity of diarrhea 2)Incidence and duration of febrile neutropenia 3)Frequency and duration of use of intravenous hyperalimentation 4)Duration of engraftment 5)Incidence and severity of acute graft-versus-host disease	—

Countries

Japan

Contacts

Public ContactKazuhiko Kakihana

Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital Hematology division

kakihana@cick.jp+81-3-3823-2101

Outcome results

None listed

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