Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Topical Diclofenac: Patients will apply 1 gram (two fingertip units) of 1 percent topical diclofenac gel on the palmar and dorsal surface of both hands twice daily from the start of cap
Sponsors
Goa Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who are planned for capecitabine treatment, either in adjuvant/neoadjuvant or palliative setting 2.Life expectancy greater than 12 weeks 3.Eastern Cooperative Oncology Group (ECOG) performance status 0 2 4.Willing and able to comply with all study requirements including applying topical gel and attending scheduled assessments 5.Signed, written informed consent
Exclusion criteria
Exclusion criteria: 1)Pre-existing grade 2 or higher neuropathy confounding assessment of HFS 2)Other dermatologic condition that may affect the hands or feet or complicate evaluation during study treatment 3)Concurrent or planned use of pyridoxine for HFS prevention 4)Known allergy or anaphylactic reactions with NSAIDs 5)History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs 6)Patients currently receiving oral or topical NSAIDs for other conditions 7)Concurrent illness including severe infection that may jeopardize safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically significant HFS (NCI CTCAE v5.0 grade greater than or equal 2).Timepoint: At baseline, every cycle of capecitabine, and at completion of four cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| All grades HFS, time to develop grade greater than or equal 2 HFS, patient-reported outcomes (HFS-14), adherence, capecitabine dose modifications, and adverse events.Timepoint: At baseline, every cycle of capecitabine, and at completion of four cycle. | — |
Countries
India
Contacts
Public ContactDr Dinesh Bhambhu
Goa medical college, Bambolim Goa
Outcome results
None listed