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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Iimura, Yohei Furukawa, Naoki Ishibashi, Masaaki Ahiko, Yuka Tanabe, Taro Aikou, Susumu Shida, Dai Nojima, Masanori Kuroda, Seiichiro Boku, Narikazu |
| Abstract | Backgrounds Clinical evidence of the preventive effectiveness of medium-class topical corticosteroids for capecitabine-induced hand foot syndrome (HFS) is limited. Although the pathogenesis and mechanism of HFS are unclear, inflammatory reactions are thought to be involved in HFS development. This study aimed to evaluate the preventive effect of medium-class topical corticosteroids (hydrocortisone butyrate 0.1% topical therapy) for capecitabine-induced HFS in patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine plus oxaliplatin. Methods This is a single-center, single-arm, phase 2 study. Patients with colorectal cancer scheduled to receive adjuvant chemotherapy with capecitabine plus oxaliplatin are enrolled, and topical hydrocortisone butyrate 0.1% is applied prophylactically in addition to standard moisturizing therapy. The primary endpoint is the incidence of grade ≥ 2 HFS within three months. The secondary endpoints are the time to onset of HFS, rates of dose reduction, schedule delay, discontinuation caused by capecitabine-induced HFS, and other adverse events. All adverse events are evaluated by clinical pharmacists and attending physicians. Discussion This study is expected to contribute to the establishment of new supportive care for preventing HFS, not only for colorectal cancer patients receiving adjuvant chemotherapy, but also for various cancer patients receiving capecitabine-based chemotherapy. Trial registration: This trial was registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs031220002. Registered 5 April 2022, https://jrct.niph.go.jp/search Protocol version V.1.0, 16 February 2022. |
| Related Links | https://bmcgastroenterol.biomedcentral.com/counter/pdf/10.1186/s12876-022-02411-w.pdf |
| Ending Page | 8 |
| Page Count | 8 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| DOI | 10.1186/s12876-022-02411-w |
| Journal | BMC Gastroenterology |
| Issue Number | 1 |
| Volume Number | 22 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2022-07-14 |
| Access Restriction | Open |
| Subject Keyword | Gastroenterology Internal Medicine Hepatology Capecitabine Hand foot syndrome Medium class topical corticosteroid Prevention |
| Content Type | Text |
| Resource Type | Article |
| Subject | Gastroenterology |
| Journal Impact Factor | 2.5/2023 |
| 5-Year Journal Impact Factor | 2.7/2023 |
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