Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer

Prior treatment

• 4\. Persistent severe diarrhea, hand-foot ulcers, or severe malnutrition at baseline that precludes tolerance of chemotherapy;
• 7\. Regular use of anti-tumor Chinese patent medicines, traditional Chinese herbal decoctions, long-term acupuncture/moxibustion for cancer treatment, or anti-cancer dietary supplements within the 2 weeks prior to enrollment, making washout period unfeasible;
• 8\. Receipt of radiation therapy, other chemotherapy drugs, targeted therapy, or immunotherapy within the month prior to enrollment;
• 9\. Patients currently undergoing double-agent chemotherapy or immunotherapy;
• 10\. Refusal to discontinue other anti-cancer traditional Chinese medicine interventions or inability to truthfully report concomitant medications.

Other illness

• 2\. History of other systemic malignancies or gastrointestinal in situ cancer within the past 5 years;
• 3\. Presence of severe underlying organic diseases affecting the heart, liver, kidneys, respiratory system, or hematopoietic system;
• 5\. Consciousness disorders or psychiatric conditions preventing independent completion of scale assessments and follow-up;
• 6\. Known allergy to any ingredient in Huangqi Yangyuan Formula or capecitabine;

Other

• 1\. Pregnant or breastfeeding women;

• 1\. Aged 18-80 years.
• 2\. Histologically confirmed stage IIIB-IV colorectal adenocarcinoma.
• 3\. Eligible for planned or ongoing capecitabine monotherapy.
• 4\. Expected survival ≥ 6 months.
• 5\. ECOG performance status 0-2.
• 6\. Baseline bone marrow, hepatic, and renal function adequate for chemotherapy.
• 7\. Able to comply with oral medication, scheduled visits, and quality-of-life assessments.
• 8\. Willing to provide written informed consent.