Trial reportInternational journal of clinical oncology2025
A phase II study evaluating the preventive effect of topical hydrocortisone for capecitabine-induced hand-foot syndrome in patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine plus oxaliplatin (T-CRACC study).
Trial report in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Chemotherapy-related hand-foot syndrome and hand-foot skin reaction: a review of management and possible approaches for Asian patients by the Japanese pharmacist-led oncodermatology study team.International journal of clinical oncology · 2025Pooled it
- Skin toxicity induced by chemotherapy or molecular targeted therapy combined with immune checkpoint inhibitors in Asian patients: A literature review by the Japanese Pharmacist-led Oncodermatology Study Team.International journal of clinical oncology · 2026Review
- Preventive and Therapeutic Interventions for Anticancer Drug-induced Dermatologic Toxicities: a Scoping Review.Current oncology reports · 2026Article
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
backgroundTopical steroids may help prevent capecitabine-induced hand-foot syndrome in patients with colorectal cancer, as inflammation is involved in anti-tumor agent-induced hand-foot syndrome development. We assessed the preventive efficacy of medium-class topical corticosteroids for capecitabine-induced hand-foot syndrome in patients receiving adjuvant chemotherapy for colorectal cancer.
methodsThis open-label, single-arm, single-center phase II study included patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine + oxaliplatin. Prophylactic topical hydrocortisone butyrate (0.1%) was applied to the palms and soles from day 1 of adjuvant chemotherapy. The primary endpoint was grade ≥ 2 hand-foot syndrome incidence within four cycles. Secondary endpoints were the time to onset and incidence of each hand-foot syndrome grade, dose reduction, schedule delay, hand-foot syndrome-induced discontinuation, and other adverse events.
resultsFifty patients were enrolled; three were excluded. Among the 47 included (median age = 54.5 years), 100% had Eastern Cooperative Oncology Group performance status 0, 36.1% were male, and 95.7% had pathological stage III disease. Hand-foot syndrome induced dose reduction, schedule delay, and discontinuation were required in 0, 2, and 0 patients, respectively, with a median relative capecitabine dose intensity of 100% within four cycles. Grade ≥ 2 hand-foot syndrome incidence during the cycles was 6.4%. Time to onset of grades ≥ 1 and ≥ 2 was 63.5 and 105.5 days, respectively. One patient experienced grade 3 hand-foot syndrome on day 164. The most common grade ≥ 2 adverse events were peripheral sensory neuropathy and neutropenia. No topical hydrocortisone butyrate (0.1%)-induced adverse events occurred.
conclusionsTopical hydrocortisone butyrate (0.1%) may prevent capecitabine-induced hand-foot syndrome.
trial registrationTrial registration number and date of registration: This clinical trial is registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs031220002).
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