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. 2022 Jul 14;22(1):341.
doi: 10.1186/s12876-022-02411-w.

Study protocol of a single-arm phase 2 study evaluating the preventive effect of topical hydrocortisone for capecitabine-induced hand-foot syndrome in colorectal cancer patients receiving adjuvant chemotherapy with capecitabine plus oxaliplatin (T-CRACC study)

Yohei Iimura  1 , Naoki Furukawa  2 , Masaaki Ishibashi  2 , Yuka Ahiko  3   4 , Taro Tanabe  3   4 , Susumu Aikou  3   4 , Dai Shida  3   4 , Masanori Nojima  5 , Seiichiro Kuroda  2 , Narikazu Boku  6
Affiliations

Study protocol of a single-arm phase 2 study evaluating the preventive effect of topical hydrocortisone for capecitabine-induced hand-foot syndrome in colorectal cancer patients receiving adjuvant chemotherapy with capecitabine plus oxaliplatin (T-CRACC study)

Yohei Iimura et al. BMC Gastroenterol. .

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.

Keywords: Capecitabine; Hand foot syndrome; Medium class topical corticosteroid; Prevention.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study scheme. HFS hand foot syndrome. Topical hydrocortisone butyrate 0.1% and standard moisturizing therapy are applied to the hands and feet daily in the morning and evening, started on day 1 and continued until the end of adjuvant chemotherapy. To keep patients’ self-adherence, all patients received standard self-care education at the start of the chemotherapy, and is confirmed the amount of topical hydrocortisone butyrate 0.1% used regularly by clinical pharmacists. Clinical pharmacists regularly educate the patients to improve self-adherence to intervention protocols
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