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A multicenter, randomized, controlled clinical study on the treatment of hand-foot skin reactions related to targeted drugs with Jiedu Yuji ointment

A multicenter, randomized, controlled clinical study on the treatment of hand-foot skin reactions related to targeted drugs with Jiedu Yuji ointment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084462
Enrollment
Unknown
Registered
2024-05-16
Start date
2024-05-22
Completion date
Unknown
Last updated
2024-05-21

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 Urea Ointment

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Malignant tumors confirmed by pathology; 2. Hand-foot skin reaction occurs, and its appearance is obviously related to targeted drug (such as anlotinib, fruquintinib, regorafenib, capecitabine, etc.); 3. KPS score > 60 points; 4. Age 18-85 years old, gender is not limited, expected survival period >= 3 months; 5. Individuals without strict center of gravity, liver, kidney, or hematopoietic system damage; 6. Clear consciousness, ability to judge and evaluate one's own pain, have high treatment compliance; 7. Patients with no local skin allergies or other skin diseases in their hands or feet before treatment; 8.Subject and family members are informed and sign consent forms

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the inclusion criteria mentioned above; 2.The clinical judgment of hand and foot skin reactions is not related to targeted drugs, such as those caused by chemotherapy drugs; 3.Symptoms of nerve compression due to advanced malignant tumors causing brain or limb metastasis or severe cervical spondylosis; Patients with nervous system diseases caused by immune system diseases, severe infections, severe diabetes, etc; 4. Pregnant women and lactating women; 5. Participants in other similar research projects on hand and foot skin reactions.

Design outcomes

Primary

MeasureTime frame
HFSR classification;

Secondary

MeasureTime frame
HFSR Specific Quality of Life Scale (HFS-14);HFSR Common Symptom Scale;Pain score;Completion rate of anti-tumor drugs;Toxic side effect assessmen;Clinical remission rate;Pain relief rate;

Countries

China

Contacts

Public ContactHuo Jiege

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

hjg16688@163.com+86 153 1201 9156

Outcome results

None listed

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