Health Condition 1: C49A- Gastrointestinal stromal tumor Health Condition 2: C254- Malignant neoplasm of endocrine pancreas Health Condition 3: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
Conditions
Interventions
Intervention1: Urea Cream: Topical application of Urea cream (10%) on both hand and foot twice daily for a period of 4 weeks with the start of sunitinib cycle
Intervention2: Urea Cream: Topical pretre
Sponsors
Dr Pooja Gupta
Dr Ranjit Kumar Sahoo
Dr T Velpandian
Dr V L Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender with age >= 18 years 2.Patients already diagnosed of cancer (Renal cell carcinoma, Gastrointestinal stromal tumour, Pancreatic neuroendocrine tumor) and were given sunitinib 3.Patients who had hand foot skin reaction to sunitinib in the previous cycle 4.Patient willing to avoid pregnancy during the study period 5.Patients must have the ability to understand and be willing to sign a written informed consent document prior to registration in the study.
Exclusion criteria
Exclusion criteria: 1.Patient receiving concomitant medication(s) known to cause or aggravate hand foot skin reaction 2.Patients receiving any other topical drug or investigational drug 3.History of allergy to urea topical application any time in the past 4.Patient with any infectious disease at present requiring pharmacotherapy (eg. Tuberculosis) 5.Co-morbid conditions like diabetes mellitus, chronic kidney disease (except in renal cancer patient), autoimmune disease like amyloidosis 6.Patients who have not recovered from adverse events due to agents administered earlier 7.Pregnant or nursing females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures: Evidence of Hand foot skin reaction during the time frame of the study -4 weeks using following parameters a. Incidence of hand foot skin reaction Timepoint: 4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures: Evidence of Hand foot skin reaction during the time frame of the study -4 weeks using following parameters a) Severity of hand foot skin reaction (I, II or III) b) Average time to the incidence of Hand foot skin reactions c) Need for sunitinib dose modification or stoppage d) Drug levels of sunitinib and its metabolite N-desethyl sunitinib (SU12662) e) Genetic polymorphism of VEGFR2 Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Pooja Gupta
All India Institute of Medical Sciences
Outcome results
None listed