Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome

NCT07883642 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: Xuxue Tongluo
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Numbness of the Four Limbs; Palmar and Plantar Erythema; Peeling of the Soles and Palms; Pain in the Distal Extremities

Keywords

Hand-foot syndrome; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Hand-Foot Syndrome Grading

  Grade 1: Numbness, paresthesia, or tingling in the hands and feet. Grade 2: Discomfort in holding objects or walking; painless swelling or erythema. Grade 3: Painful erythema, edema of the palms and soles, periungual erythema, and swelling. Grade 4: Desquamation, ulceration, blistering, and severe pain.

  on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention

Secondary Outcomes (3)

• numeric rating scale (NRS) score

  on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention

• capecitabine dose maintenance rate

  on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention

• Quality of life score (EORTC QLQ-C30)

  on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention

Study Arms (2)

raditional Chinese medicine fumigation and washing intervention group

EXPERIMENTAL

Standard Basic Care + Hand and Foot Bath with Twelve-Ingredient Processed Sichuan Aconite 1 Fixed Formula (Uniformly and Independently Packaged by the Hospital's Traditional Chinese Medicine Pharmacy) Shenjincao 15 g, Jixueteng 15 g, Processed Sichuan Aconite 10 g, Guizhi 15 g, Yinyanghuo 15 g, Honghua 15 g, Xixin 5 g, Weilingxian 15 g, Huangqi 30 g, Angelica sinensis 15 g, Paeonia rubra 15 g, Artemisia argyi 15 g; The outer packaging must clearly state "For external use only; do not take orally," and separately indicate the requirement to decoct processed Aconite root first. 7.2.2 Standardized Decoction Procedure 1.1. Soak all herbal ingredients in clean water for 30 minutes; 2.2. Add water to the processed Aconite (Zhi Chuan Wu) separately and decoct for 30-60 minutes to reduce toxicity; then add all remaining herbal ingredients. This decoction protocol complies with the Pharmacopoeia and the unified toxicity-reduction standards for external preparations containing Aconite \[9\]; 3.

Drug: Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath

Control Group

PLACEBO COMPARATOR

1.1. 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; 2.2. Daily Protection Education: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and exposure to direct sunlight. The standard Western medical care protocol is uniformly recommended by current domestic and international guidelines \[3\]; 3.3. Symptomatic Treatment: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal 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.

Other: Standard Basic Nursing Interventions

Interventions

Standard Basic Nursing Interventions OTHER

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.

Control Group

Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath DRUG

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.

raditional Chinese medicine fumigation and washing intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years， Open to all genders;
• Currently receiving adjuvant or palliative chemotherapy with capecitabine monotherapy or the XELOX regimen, and expected to continue capecitabine treatment;
• Patients with Grade 1-2 hand-foot syndrome as confirmed by CTCAE v5.0 \[1\], as well as some patients with Grade 3 hand-foot syndrome as assessed by the investigator (those with dry, crusted lesions, old skin lesions, and no signs of acute inflammation) may undergo hand and foot baths;
• ECOG performance status of 0-2, able to independently perform hand and foot baths, and able to attend weekly outpatient follow-up visits;
• Fully informed about all aspects of the study and voluntarily signed a written informed consent form.

You may not qualify if:

• Patients with Grade 3 CTCAE hand-foot syndrome (with active, extensive ulceration, exudation, or secondary acute bacterial/fungal skin infections) who are not suitable for hand and foot baths; Note: Patients with dry crusting, chronic skin lesions, or no signs of acute inflammation are not excluded;
• Patients with an allergy to any of the Chinese herbal ingredients in the formula when used topically;
• Pregnant or breastfeeding women;
• Patients with baseline severe hepatic or renal impairment, persistent arrhythmias, or prolonged QT interval;
• Patients concurrently taking or applying other herbal preparations containing aconite \[9\];
• Patients with severe diabetic peripheral neuropathy and significantly diminished pain and temperature sensation in the hands and feet;
• Patients with mental disorders or cognitive impairment who are unable to comply with home herbal baths and follow-up visits.

Sponsors & Collaborators

• Emeishan Hospital of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Central Study Contacts

WLiBo Wu

CONTACT

18784644364; 1071089518@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Model Details: This study employs a prospective, randomized, parallel-group design. The specific randomization process is as follows: 1.1. A 1:1 allocation ratio is used via a centralized randomization system (or a computer-generated random sequence combined with the sealed-envelope method); 2.2. Block randomization is employed, with block sizes set at 4-6. A random sequence is generated in advance by an independent statistician to ensure allocation concealment; 3.3. Patients who met the inclusion criteria and signed the informed consent form received a sealed randomization envelope with a corresponding number in the order of enrollment; the study coordinator opened the envelope to determine the group assignment; 4.4. The randomization sequence was kept by an independent statistician; the principal investigator and clinical evaluators did not participate in the randomization process; 5.5. Timing of randomization: Randomization was completed after the informed consent form was signed during the baseli

Study Record Dates

• First Submitted: October 11, 2026
• First Posted: October 20, 2026
• Study Start: October 1, 2026
• Primary Completion: October 20, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 20, 2026

Record last verified: 2026-10