To analyse the effect of topical application of urea based cream on hand foot skin reaction (which is a side effect) caused by sunitinb in cancer patients
- Conditions
- Health Condition 1: C49A- Gastrointestinal stromal tumorHealth Condition 2: C254- Malignant neoplasm of endocrine pancreasHealth Condition 3: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
- Registration Number
- CTRI/2019/10/021500
- Lead Sponsor
- Dr Pooja Gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measures: Evidence of Hand foot skin reaction during the time frame of the study -4 weeks using following parameters <br/ ><br>a.Incidence of hand foot skin reaction <br/ ><br>Timepoint: 4 week
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures: Evidence of Hand foot skin reaction during the time frame of the study -4 weeks using following parameters <br/ ><br>a)Severity of hand foot skin reaction (I, II or III) <br/ ><br>b)Average time to the incidence of Hand foot skin reactions <br/ ><br>c)Need for sunitinib dose modification or stoppage <br/ ><br>d)Drug levels of sunitinib and its metabolite N-desethyl sunitinib (SU12662) <br/ ><br>e)Genetic polymorphism of VEGFR2 <br/ ><br>Timepoint: 4 weeks