Health Condition 1: C15-C26- Malignant neoplasms of digestive organs Health Condition 2: C50-C50- Malignant neoplasms of breast
Conditions
Interventions
Intervention1: 12% urea cream: Patients will be instructed to use 12 percent urea cream on both hands and feet, three times a day as well as after washing hands for 6 weeks
Control Intervention1: obs
Sponsors
no sponsor
Eligibility
Inclusion criteria
Inclusion criteria: Patients with gastrointestinal malignancies of breast cancer initiating capecitabine treatment at a dose of at least 1000mg/m2 twice daily as monotherapy or combination therapy, ECOG PS less than 3, adequate bone marrow function
Exclusion criteria
Exclusion criteria: Patients with any dermatological toxicity other than alopecia that has not resolved, creatinine clearance of <30ml/min as per Cockcroft gault formula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to assess the efficacy of urea cream vs placebo to prevent HFS of any grade within a 6-week period.Timepoint: at baseline, 3 weeks and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| time to development of HFS time to capecitabine dose interruption, evaluation of capecitabine dose intensity quality of life analysesTimepoint: at baseline, 3 weeks and 6 weeks | — |
Countries
India
Contacts
Public ContactGayathri R Nair
Madras Medical College
Outcome results
None listed