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Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Sponsor: Emeishan Hospital of Traditional Chinese Medicine
Summary
This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the 'Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The research hypothesis is that adding this traditional Chinese medicine hand and foot bath to standard baseline care will result in a significantly higher efficacy rate-defined as a ≥1-grade reduction in Hand-Foot Syndrome (HFS) severity after 3 weeks-compared to baseline care alone.The study plans to enroll 110 patients with capecitabine-related Grade 1-2 HFS (with some eligible Grade 3 patients), who will be randomized in a 1:1 ratio to the control group and the intervention group. The control group will receive standard baseline care; the intervention group will receive standard baseline care supplemented with a fixed 12-ingredient traditional Chinese medicine hand-and-foot bath, in which processed Aconite is pre-decocted to reduce toxicity. Patients will soak their hands and feet in the decoction at 38-41°C at least 4 times per week for 3 consecutive weeks.Primary endpoint: The proportion of patients with a ≥1-grade reduction in HFS score from baseline after 3 weeks of intervention.
Official title: A Randomized Cpntrolled Trial Protocol of Xuxue Tongluo for Capecitabine-Related Hand-Foot Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
7
Start Date
2026-10-01
Completion Date
2026-12-01
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath
Prepare a traditional Chinese medicine decoction, maintain the temperature of the decoction between 38 and 41°C, completely submerge both hands and feet in the decoction for 15 to 20 minutes, soak at least 4 times a week, and continue the treatment for 3 consecutive weeks.
Standard Basic Nursing Interventions
1\. Basic Care: Gently wash hands and feet daily with warm water, and apply a generous amount of non-irritating medical-grade moisturizer to both hands and feet; 2. Education on Daily Protection: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and excessive sun exposure. This is the standard Western medical care protocol uniformly recommended by current domestic and international guidelines \[3\]; 33. Symptomatic Management: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal foot baths or topical herbal preparations is strictly prohibited throughout the entire treatment period; 4. Intervention Period: Provide continuous, standardized care for 3 weeks, with weekly outpatient follow-up evaluations.