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Fat Emulsion to Prevent Allergic Reactions in Cancer Patients
N/A
Waitlist Available
Led By Aminah Jatoi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Advanced, incurable cancer
Anticipated 2 or more subsequent chemotherapy infusions of either carboplatin or oxaliplatin at the time of study registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether giving fat emulsion before carboplatin or oxaliplatin chemotherapy can prevent reactions to the drugs.
Who is the study for?
This trial is for adults with advanced, incurable cancer who are receiving carboplatin or oxaliplatin and have not had previous allergic reactions to these drugs. Participants must have normal liver function tests, acceptable triglyceride levels, and be willing to provide blood and urine samples. They should not be taking certain anti-inflammatory drugs or have allergies to eggs.Check my eligibility
What is being tested?
The study is testing whether a fat emulsion given before chemotherapy can prevent allergic reactions in patients treated with carboplatin or oxaliplatin. Patients are randomly assigned to receive either the fat emulsion or a placebo (a substance with no active drug) before their chemotherapy treatment.See study design
What are the potential side effects?
Potential side effects of the fat emulsion may include discomfort at the injection site, changes in blood lipid levels, and possible interference with the effectiveness of chemotherapy drugs. The specific side effects will be monitored closely throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
My cancer cannot be cured and is in an advanced stage.
Select...
I am expected to receive at least 2 more chemotherapy treatments with carboplatin or oxaliplatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (fat emulsion)Experimental Treatment1 Intervention
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.
Group II: Group II (placebo)Placebo Group1 Intervention
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.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,134 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,765 Total Patients Enrolled
Aminah JatoiPrincipal InvestigatorMayo Clinic
8 Previous Clinical Trials
243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking liposomal doxorubicin or a similar drug.I have not taken aspirin, NSAIDs, or zileuton in the last 7 days.My cancer cannot be cured and is in an advanced stage.I am scheduled for my 7th or later carboplatin or oxaliplatin infusion, or it's been 4 months since my first cycle.I am expected to receive at least 2 more chemotherapy treatments with carboplatin or oxaliplatin.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (fat emulsion)
- Group 2: Group II (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for participants in this trial?
"The clinical trial's information on clinicaltrials.gov reveals that this particular study is no longer seeking applicants, having been initially posted in July 2017 and last updated 6th of July 2022. However, there are presently 2,632 other trials actively recruiting participants."
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