Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
- Participants will come in for chemotherapy treatment as scheduled by their oncologist.
The frequency of the visits will depend upon the chemotherapy regimen the participant
- With each visit, the participants will have a physical exam and will be asked questions
about their general health and specific questions about any problems that they might be
having and any medications they may be taking. At each of these visits, routine blood
work will be taken to monitor the participant's health.
- While the participants are receiving oxaliplatin, the infusion nurse will monitor them
for any evidence of hypersensitivity reaction. Participants will also leave with a
diary to record any symptoms that may occur for 24 hours after they have completed the
infusion of oxaliplatin.
- In the optional portion of the study, participants will undergo allergy skin testing in
the Allergy Service at Brigham and Women's Hospital The skin testing will be done at
three time points: before the first dose of oxaliplatin, before the 5th dose of
oxaliplatin, and before the 10th dose of oxaliplatin.
- Desensitization is a method used to help a person with an allergy tolerate exposure to
a specific allergic agent. Desensitization to a medication such as oxaliplatin
involves giving the medication in slowly increasing amounts, starting with tiny doses,
and ending with the full dose prescribed by the physician. Patients participating in
this part of the study will have the desensitization at Brigham and Women's Hospital in
the Medical Intensive Care Unit (ICU or MICU) to ensure close supervision.
Desensitization to oxaliplatin involves a multi-step procedure where the oxaliplatin
dose is started at very small doses and the rate of infusion is increased every 15
minutes until the "target rate" is achieved. This rate is then maintained until the
full dose of medication has been infused. This usually takes approximately 6 hours if
no adverse reactions are experienced.
Observational Model: Case-Only, Time Perspective: Prospective
To determine prospectively the incidence and severity of hypersensitivity reactions to oxaliplatin among patients beginning treatment with oxaliplatin during a two-year observation period.
Jennifer A. Chan, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|