Herbal Decoction Added to Capecitabine for Advanced Colorectal Cancer Side Effects
Tests a herbal decoction with capecitabine in adults with advanced colorectal cancer.
Plain-language title generated from the registry record
Registry title: Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer
Key facts
- Where
- Shijiazhuang, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07913516, who can take part
Where in China
- Hebei Provincial Hospital of Traditional Chinese MedicineShijiazhuang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huanfang Fan
- Trial code
- NCT07913516
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Prospective Single-Arm Feasibility Clinical Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Patients With Advanced Colorectal Cancer
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.
Inclusion: 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.
Exclusion: 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; 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; 1. Pregnant or breastfeeding women.