Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin
NCT ID: NCT03122886
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2017-07-14
2019-07-31
Brief Summary
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Detailed Description
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I. To determine if the infusion of a lipid emulsion before each dose of chemotherapy appears to prevent carboplatin and oxaliplatin hypersensitivity reactions in high-risk patients.
II. To explore if lipid infusions modulate a well-established panel of mediators of hypersensitivity reactions and if these mediators appear to predict reactions.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive fat emulsion intravenously (IV) immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (fat emulsion)
Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Fat Emulsion
Given IV
Group II (placebo)
Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Placebo
Given IV
Interventions
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Fat Emulsion
Given IV
Placebo
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Aminah Jatoi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2017-00495
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC16C1
Identifier Type: OTHER
Identifier Source: secondary_id
16-007773
Identifier Type: OTHER
Identifier Source: secondary_id
MC16C1
Identifier Type: -
Identifier Source: org_study_id