Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer

Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer - Clinical study of TJ-14 for oral mucositis with chemotherapy and radiotherapy in head and neck cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014857

Enrollment

Registered

2014-09-01

Start date

2014-09-01

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

Head and neck malignant cancer

Interventions

Oral administration of TJ-14 7.5g/day between meals. Oral administration of placebo 7.5g/day between meals.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with radiation or chemotherapy for head and neck cancer Patients that oral care is possible Performance status of 0 or 1 Patients that communication is possible Patients have adequate function of vital organ Patients provide written informed consent before initiation of study

Exclusion criteria

Exclusion criteria: Patients that had used Kampo medicine within 1 month before registration Patients that have an allergy for TJ-14 Patients that don't hope for participation in this study Interruption of the treatment over 1 month Serious psychiatric disorder Patients that will be inappropriate for entry into this study in the judgment of the investigator.

Design outcomes

Primary

Measure	Time frame
The inflammatory marker (IL-1, TNF-alpha, PGE2), oxidant stress marker (8-OHdG, AGEs, 8-isoprostane), antioxidant biomarker [SOD, TAC(total antioxidant capacity)]	—

Countries

Japan

Contacts

Public ContactKenkichiro Taira

Tottori University Hospital Depertment Otolaryngology:Head and Neck surgery

kenkichiro.t@med.tottori-u.ac.jp0859-38-6627

Outcome results

None listed

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