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Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer
Sponsor: Huanfang Fan
Summary
This is a single-center, prospective, open-label, single-arm feasibility study. Thirty-five patients with stage IIIB-IV colorectal adenocarcinoma undergoing capecitabine monotherapy will be enrolled. All participants will receive oral capecitabine (1250 mg/m2, twice daily, 14 days on/7 days off, 21-day cycle, up to 8 cycles) combined with Huangqi Yangyuan Formula (a Chinese herbal decoction, 150 mL twice daily). The primary objective is to evaluate the completion rate of standardized capecitabine chemotherapy at 4 and 8 cycles. Secondary outcomes include chemotherapy-related adverse events (CTCAE v5.0), quality of life (EORTC QLQ-C30), traditional Chinese medicine constitution scores (BCQ), disease-free survival at 3-month follow-up, peripheral blood T-lymphocyte subsets, and safety laboratory indicators.
Official title: A Prospective Single-Arm Feasibility Clinical Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Patients With Advanced Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2027-01-01
Completion Date
2029-12-31
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
Capecitabine
Oral capecitabine at 1250 mg/m2 twice daily, taken within 30 minutes after meals, days 1-14 followed by 7 days rest per 21-day cycle, for up to 8 cycles. Dose adjustments are permitted per clinical guidelines based on toxicity.
Huangqi Yangyuan Formula (Chinese Herbal Decoction)
A nine-herb Chinese medicinal decoction prepared in-house, including Radix Astragali (Huang Qi), Radix Rehmanniae Preparata (Shu Di Huang), and seven additional herbs. Each dose is 150 mL, administered orally twice daily, taken 30 minutes apart from capecitabine. Treatment starts at cycle 1 and continues through 8 cycles, with a 1-week interruption at the end of cycle 4.
Locations (1)
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei Provincial, China