Cancer
Conditions
Interventions
Experimental group:Patients treated with CICAPLAST BAUME B5+
twice a day, apply to hand and feet (or adjust for specific skin adverse reactions).Follow up 8week ±3days.
Control Group:Patients treated with Silicone Oil Cream
twice a day, apply to hand and feet (or adjust for specific skin adverse reactions),Follow up 8week ±3days.
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 Capecitabine; 3.Adverse skin reactions (Hand and foot skin reactions, skin itching, dryness, color change, chapped skin, etc.) occurred during Capecitabine 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 |
|---|---|
| Hand-foot syndrome grading improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Transepidermal water loss (TEWL);Skin colorimetry (colorimeter);Visual Analogue Scale (VAS);Dermatology Quality of life index(DLQI);Patient Unique Stigmatization Holistic tool in dermatology (PUSH-D) questionnaire;Improvement Time by Severity of Hand-Foot Syndrome; | — |
Countries
China
Contacts
Public ContactYin Yongmei
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed