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A multicenter, randomized controlled study of recombinant human epidermal growth factor gel combined with urea ointment versus urea ointment in the treatment of moderate-to-severe hand-foot syndrome caused by multi-targeted kinase inhibitors in cancer patients

A multicenter, randomized controlled study of recombinant human epidermal growth factor gel combined with urea ointment versus urea ointment in the treatment of moderate-to-severe hand-foot syndrome caused by multi-targeted kinase inhibitors in cancer patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055384
Enrollment
Unknown
Registered
2022-01-08
Start date
2022-01-04
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

hand-foot skin reaction (HFSR)

Interventions

Experimental group:Recombinant human epidermal growth factor gel combined with urea ointment

Sponsors

Zhongshan Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged above 18 years, no gender limit; 2. Cancer patients taking anticancer drugs and with HFS/HFSR grade II or higher, and the expected treatment time of anticancer drugs is >=6 weeks (42 days); 3. Expected survival time > 6 months; 4. If HFS/HFSR was being treated with various modalities prior to enrollment, it was required to be ineffective for the treatment used. And the drug for HFS/HFSR should be discontinued for >=1 week before randomization; 5. If patients have used drugs to prevent HFS/HFSR before enrollment, but the preventive effect is not good, they can be enrolled after the occurrence of 2nd degree HFS/HFSR, but the preventive drugs need to be stopped for >=1 week. Or if the patient requests to continue to use the original prophylactic drug, the prophylactic drug is required for external use, and the original prophylactic regimen needs to be adhered to throughout the observation period of the trial; 6. ECOG score <= 2; 7. No history of serious heart, lung, liver, kidney and other important organ diseases; 8. Sign the informed consent; 9. Good patient compliance.

Exclusion criteria

Exclusion criteria: 1. Those with preexisting nervous system diseases; 2. Diabetes complicated with nervous system diseases; 3. Patients who are receiving other non-targeted drug therapy that may cause hand-foot syndrome; 4. Poor compliance; 5. Uncontrolled infections and metabolic diseases; 6. Pregnant or mentally ill patients.

Design outcomes

Primary

MeasureTime frame
Ratio of HFS/HFSR recovery to 1 degree and ratio of recovery to 0 degree;

Secondary

MeasureTime frame
Improvement score of common symptoms of tumor;Improvement in quality of life score;

Countries

China

Contacts

Public ContactMeng Jincheng

Zhongshan Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine

286983099@qq.com+86 18938799001

Outcome results

None listed

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