Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007773
NCT ID: NCT03122886
Sponsor Protocol Number: MC16C1
About this study
This randomized pilot trial studies how well fat emulsion works in preventing hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin. Giving lipids before chemotherapy may prevent some drug reactions from carboplatin or oxaliplatin.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Advanced, incurable cancer
- 7th or later cycle of intravenous carboplatin or oxaliplatin infusion planned or 4 months after the first cycle of agent (whichever is of longer duration) =< 30 days after registration
- Anticipated 2 or more subsequent chemotherapy infusions of either carboplatin or oxaliplatin at the time of study registration; NOTE: the dose of carboplatin or oxaliplatin, choice of other chemotherapy, and other ancillary treatment, such as antiemetics, will be left to the discretion of the treating healthcare provider
- Willing to provide mandatory blood and urine specimens for correlative research; NOTE: can be waived with permission of study chair (documentation such as an email must be provided)
- Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN); NOTE: can be waived with permission of study chair (documentation such as an email must be provided)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal
- Triglycerides < 500 mg/dL
- Alkaline phosphatase =< 3 x the institutional upper limit of normal
Exclusion Criteria:
- Concurrent liposomal doxorubicin or any other liposomal agent
- Prior carboplatin or oxaliplatin hypersensitivity reaction
- Taking aspirin, nonsteroidal anti-inflammatory agents, or zileuton =< 7 days prior to registration; NOTE: can be waived with permission of study chair (documentation such as an email must be provided)
- Allergy to egg or egg byproducts
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Aminah Jatoi, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available