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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

Must not have

Concurrent liposomal doxorubicin or any other liposomal agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

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.

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.

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 “Yes” for the criteria below

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My cancer cannot be cured and is in an advanced stage.

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I am expected to receive at least 2 more chemotherapy treatments with carboplatin or oxaliplatin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking liposomal doxorubicin or a similar drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 3Eligibility criteria met