臨床研究等提出・公開システム

Parallel competitive study in two groups to examine the effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy (Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation)

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

Namiki Takao

Chiba University Hospital

1-8-1 Inohana Chuo-ku, Chiba City, Japan

tnamiki@faculty.chiba-u.jp

Namiki Takao

Medical Mycology Research Center, Chiba University

1-8-1 Inohana Chuo-ku, Chiba City, Japan

+81-43-222-7171

tnamiki@faculty.chiba-u.jp

Recruiting

Sept. 19, 2017

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1.Patients receiving radiation therapy (60Gy) combined with anti-cancer medication (cisplatin) for head and neck cancer (oral, oro- and hypo-pharyngeal cancer)
2.Those who are 20 years of age or older at the time of obtaining informed consent
3.Those who have received sufficient explanation and have given written informed consent of their own or their legal guardian's consent to participate in this study with full understanding

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

Both

oral mucositis

medication

Radiation therapy, anticancer drugs

D013280

Maximum Grade in severity score for oral mucositis :NCI-CTC/CTCAE V4

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

+81-43-226-2616

Mar. 22, 2019

none