Cancer
Conditions
Interventions
Test group:Patients treated with CICAPLAST BAUME B5+
twice a day, apply to skin lesions such as head, neck, trunk, limbs, hands and feet (adjust according to the specific location of skin adverse reactions).Follow up 8 weeks +/-3 days
Control Group:Patients treated with Dimethicone Cream
twice a day, apply to skin lesions such as head, neck, trunk, limbs, hands and feet (adjust according to the specific location of skin adverse reactions) .Follow up 8 weeks +/-3 days
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, Male and Female 2. Pathological diagnosis of malignant tumor patients, the current treatment regimen includes EGFR inhibitors (Cetuximab, Osimertinib, Gefitinib, Erlotinib, Pyrotinib, Lapatinib, etc.) 3. Adverse skin reactions (rash, hand and foot skin reactions, skin itching, dryness, color change, chapped skin, etc.) occurred during EGFR inhibitor treatment 4. Able and willing to continue to use the experimental product during the clinical study, with good compliance; 5. Estimated patient survival time >1 year; 6. ECOG score 0-1; 7. Patients voluntarily participated in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Metastatic or primary skin cancer, any pre-existing skin condition that could have affected the study results (e.g. Atopic Dermatitis, contact dermatitis, psoriasis, rosacea, severe photosensitivity, scleroderma, xerosis) and any known cosmetic allergies; 2.Radiotherapy for concomitant malignant tumors; 3.Persons without personal freedom and independent capacity for civil conduct; 4.There are mental disorders, addiction and other conditions, and the researchers judge that they are not eligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rashes grading improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS);transepidermal water loss (TEWL);Skin colorimetry (colorimeter);Dermatology Quality of life index(DOQL);Patient Unique Stigmatization Holistic tool in dermatology (PUSH-D) questionnaire; | — |
Countries
China
Contacts
Public ContactYin Yongmei
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed