Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05922358 |
Other study ID # |
SYLT-027 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
September 1, 2023 |
Est. completion date |
September 1, 2026 |
Study information
Verified date |
June 2023 |
Source |
Fujian Cancer Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of
severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to
prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to
evaluate the use of effective anti-allergic and desensitization therapies to enable patients
who are already allergic to oxaliplatin to complete their prescribed doses smoothly.
Description:
The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of
severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to
prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to
evaluate the use of effective anti-allergic and desensitization therapies to enable patients
who are already allergic to oxaliplatin to complete their prescribed doses smoothly.
Patients with GI receiving oxaliplatin-containing regimens were prospectively observed, and
patients with oxaliplatin grade I-III hypersensitivity reactions judged by clinicians based
on clinical symptoms and signs entered the oxaliplatin reuse study . For patients with grade
I-III oxaliplatin allergy, oxaliplatin skin test with 3 concentration gradients (0.01 mg/ml,
0.1 mg/ml and 5 mg/ml) was performed, and 5% glucose Water served as a negative control.
15-20 minutes to read test results. If the largest diameter of the rash was greater than 3 mm
of the negative control, it was judged as a positive result. Afterwards, interventions were
performed in different ways according to the grade of oxaliplatin allergic reaction.