Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy

JRCT ID: jRCT1031190210

Registered date:13/02/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: oral mucositis
• Date of first enrollment: 30/11/2017
• Target sample size: 30
• Study type: Interventional
• Intervention(s): medication

Outcome(s)

• Primary Outcome: Maximum Grade in severity score for oral mucositis :NCI-CTC/CTCAE V4
• Secondary Outcome: Performance status (PS: ECOG), period of Grade 2 or higher, period of Grade 3 or higher, hospitalization, opioid usage, period from the end of radiation treatment to the start of oral intake

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients receiving radiation therapy (60Gy) combined with anti-cancer medication (cisplatin) for head and neck cancer (oral, oro- and hypo-pharyngeal cancer)

Exclude criteria

1. Patient who cannot take Kampo medications at start of this research
2. Patient with allergy for oren-to
3. Patient who is judged to be inappropriate to carry out the research safely by the principal or sub investigator

Related Information

• Primary Sponsor: Namiki Takao
• Secondary ID(s): UMIN000030091