Skip to content

A Multicenter, Randomized, Controlled Clinical Study of Jiedu Yuji Ointment in the Treatment of Antineoplastic Drug-related Hand-Foot Skin Reaction

A Multicenter, Randomized, Controlled Clinical Study of Jiedu Yuji Ointment in the Treatment of Antineoplastic Drug-related Hand-Foot Skin Reaction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107025
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand-foot skin reactions

Interventions

Control group:Use 10% Urea Ointment

Sponsors

Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically or cytologically confirmed malignant tumors (hepatocellular carcinoma can be without pathology but must meet clinical diagnostic criteria); 2. Receiving anti-tumor drugs including chemotherapy drugs, MKIs, VEGFR-TKIs (capecitabine, sorafenib, regafinib, cabozantib, apatinib, anlotinib, fruquintinib, lenvatinib, etc.), other anti-tumor drugs such as single agent or combination therapy; 3. Skin reactions of hands and feet with degree II-III (refer to NCI-CTCAE5.0 grade criteria for adverse skin reactions) after anti-tumor treatment; 4. Age 18-85 years old (including boundary value), gender is not limited; 5. KPS score > 60 points, pre-survival >=3 months; 6. Clear awareness, ability to judge and evaluate their own pain and other symptoms; 7. No obvious skin allergies and other skin diseases on the skin of the hands and feet before treatment. 8. Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those with other skin lesions in the hands and feet (such as skin ulceration of the hands and feet caused by diabetes, fungal infection of the hands and feet, skin trauma, etc.), which affects the judgment of efficacy; 2. Pregnant and lactating women; 3. Participated in other hand and foot skin reaction drug intervention researchers in the past 1 month; 4. Known allergy to the drugs in this study.

Design outcomes

Primary

MeasureTime frame
HFSR classification;

Secondary

MeasureTime frame
HFSR-specific quality of life scale score;HFSR Common Symptom Scale score;Pain score;Antineoplastic Drug Dose Adjustment (Reduction/Discontinuation) Rate;Adverse Event Assessment;Clinical remission rate;

Countries

China

Contacts

Public ContactWei Guoli

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

weiguoli1987@163.com+86 173 2700 6155

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026