NCT03122886

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 20, 2020

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

March 28, 2017

Results QC Date

May 12, 2020

Last Update Submit

December 2, 2024

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction

    The primary endpoint is the time to healthcare provider reported hypersensitivity reactions from either carboplatin or oxaliplatin. Kaplan Meier curves will be constructed and a log-rank test will be used to compare time-to-hypersensitivity reaction between treatment arms. Data will be censored based on last infusion with no hypersensitivity reaction with a maximum study treatment duration of 2 years per patient.

    Up to 2 years

Study Arms (2)

Group I (fat emulsion)

EXPERIMENTAL

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.

Dietary Supplement: Fat Emulsion

Group II (placebo)

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Fat EmulsionDIETARY_SUPPLEMENT

Given IV

Also known as: FAT EMULSION, INTRAVENOUS, Intralipid, Intravenous Fat Emulsion
Group I (fat emulsion)
PlaceboOTHER

Given IV

Also known as: placebo therapy, PLCB, sham therapy
Group II (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced, incurable cancer
  • th 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

soybean oil, phospholipid emulsionFat Emulsions, Intravenous

Intervention Hierarchy (Ancestors)

EmulsionsColloidsDosage FormsPharmaceutical PreparationsParenteral Nutrition SolutionsPharmaceutical SolutionsSolutionsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
Aminah Jatoi, MD
Organization
Mayo Clinic
Jatoi.Aminah@mayo.edu
507/284-2511

Study Officials

  • Aminah Jatoi, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 21, 2017

Study Start

July 14, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

December 17, 2024

Results First Posted

May 20, 2020

Record last verified: 2024-12

Locations

US(1)