Trial reportFrontiers in pharmacology2026
Efficacy and safety of TiaoPi AnChang decoction to reduce CAPOX-Induced adverse reactions in Chinese patients with colorectal cancer: a randomized, double-blind, placebo-controlled trial.
Trial report in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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16 authors.
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Abstract
Purpose: This study evaluated the efficacy of TiaoPi AnChang Decoction (TPACD) against CAPOX-induced adverse reactions (CIARs) and improving survival outcomes in colorectal cancer (CRC) patients receiving CAPOX as adjuvant chemotherapy. This paper presents an interim analysis of the clinical trial, with a primary focus on CIARs. Patients and methods: This was a randomized, double-blind, placebo-controlled trial enrolling high-risk stage II or III CRC patients undergoing CAPOX who were diagnosed with spleen-kidney deficiency syndrome. The study planned to randomly assign 98 patients in a 1:1 ratio to either the TPACD group (30 mL orally, twice daily) or the placebo group (matched placebo). The trial duration spanned 4 chemotherapy cycles (approximately 84 days), during which we assessed the incidence of CIARs (graded via CTCAE), Traditional Chinese Medicine (TCM) syndrome scores, quality of life (QoL, evaluated via EORTC QLQ-C30), peripheral blood immune cell subsets, tumor markers, safety, and survival outcomes. A linear mixed-effects model was applied to adjust for baseline differences. Results: Among 496 screened CRC patients, 108 were randomized into the TPACD group (n = 54) or the placebo group (n = 54). The incidence of overall CIARs was significantly lower in the TPACD group ( Conclusion: TPACD serves as an effective, safe, well-tolerated, and readily acceptable complementary therapy for CRC patients undergoing CAPOX. Clinical Trial Registration: https://www.chictr.org.cn/index.html, identifier ChiCTR2200065759.
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