Patient with stage III-IV colorectal cancer oxaliplatin, hypersensitivity reactions (HSRs), venous pain, numerical rating scale (NRS)
Conditions
Interventions
we randomly assigned patients with stage III-IV colorectal cancer to received intervention arm
Arm A (Y-site co-infusion of oxaliplatin and dexamethasone) at the 4th cycle of CAPEOX regimen to completed of the 8th cycle. We compare the incidence of hypersensitivity reactions (HSRs) and degree
Arm B (standard of dexamethasone premedication) at the 4th cycle of CAPEOX regimen to completed of the 8th cycle. We compare incidence of HSRs and degree of venous pain between intervention arm and p
Experimental Device,Placebo Comparator Device
Y-site co-infusion of oxaliplatin and dexamethasone,standard dexamethasone premedication
Sponsors
Phramongkutklao Hospital and College of Medicine
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged at least 20 years with histologically confirmed colorectal cancer stage III-IV. 2. Patient receiving CAPEOX regimen at least 4 cycles 3. ECOG performance status 0-1 4. Adequate organ function
Exclusion criteria
Exclusion criteria: 1. History allergy to steroid, oxaliplatin or capecitabine 2. Prior use of oxaliplatin 3. Current use of steroid, antihistamine and anti-leukotrienes treatments 4. Peripheral neuropathy 5. Uncontrolled HT, DM, CAD 6. On Port-A-Cath insertion 7. Received medication for any kind of pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of HSRs and degree of venous pain 1 year frequency and percentage | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate 1 year frequency and perentage,progression free survival 1 year log-rank test,adverse events 1 year frequency an percentage | — |
Countries
Thailand
Contacts
Public ContactSiriwimon Saichaemchan
Phramongkutklao hospital and college of medicine
Outcome results
None listed