A randomized, double-blind, placebo-controlled phase III study evaluating the preventive effect of diclofenac cream on capecitabine-related hand-foot syndrome: study protocol of J-SUPPORT2401/JORTC-SUP06 (J-DIRECT)
If this study meets the primary endpoint, a new standard preventive therapy for HFS will be established. Moreover, the use of topical diclofenac cream alongside high-dose capecitabine may enhance chemotherapy efficacy.
Authors
- Tomoya Yokota (ORCID: https://orcid.org/0000-0001-7327-7949)
- Narikazu Boku (ORCID: https://orcid.org/0000-0002-1438-707X)
- Hiromichi Matsuoka (ORCID: https://orcid.org/0000-0002-7276-1971)
- Noriko Fujiwara (ORCID: https://orcid.org/0000-0001-8201-9490)
- Sadamoto Zenda (ORCID: https://orcid.org/0000-0002-0421-5805)
- Seiichiro Kuroda
- Masanori Nojima (ORCID: https://orcid.org/0000-0002-8788-2522)
- Keita Mori (ORCID: https://orcid.org/0000-0002-5473-1488)
- Shunsuke Oyamada (ORCID: https://orcid.org/0000-0002-8130-6815)
- Yohei Iimura (ORCID: https://orcid.org/0000-0002-3473-8244)
- Hironobu Hashimoto (ORCID: https://orcid.org/0000-0002-5907-5547)
- Hiroshi Ishiguro (ORCID: https://orcid.org/0000-0002-0805-7648)
- Satoshi Hirakawa (ORCID: https://orcid.org/0000-0003-2510-8985)
- Keisuke Ariyoshi
Institutions
- National Cancer Centre Japan (JP)
- Shizuoka Cancer Center (JP)
- National Cancer Center (US)
- University of Tokyo Hospital (JP)
- Seirei Hamamatsu General Hospital (JP)
- National Cancer Center Hospital East (JP)
- Japan Clinical Cancer Research Organization (JP)
- Tokyo National Hospital (JP)
- The University of Tokyo (JP)
- Saitama Medical University (JP)
Publication Details
- Journal
- International Journal of Clinical Oncology
- Published
- 2025-05-14
- DOI
- https://doi.org/10.1007/s10147-025-02789-z
- Citations
- 3
- Primary Topic
- Chemotherapy-related skin toxicity
- Type
- article
- Field-Weighted Citation Impact
- 6.01
Funders
- University of Tokyo
- Institute of Medical Science, University of Tokyo