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Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity

Primary Purpose

Hypersensitivity Reactions

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypersensitivity Reactions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult female patients > 18 years of age
  2. Patients of the Loma Linda University Health (LLUH) gynecologic oncology and breast oncology service
  3. Confirmed breast or gynecologic cancer diagnosis of any stage and any gynecologic or breast malignancy
  4. Planned treatment with paclitaxel containing regimen either in the adjuvant setting or for palliation
  5. Planned treatment with paclitaxel should be for 3 or more cycles given as a weekly or every 3 weeks cycle

  6. Paclitaxel should be given as a monotherapy or as part of a combination regimen. If paclitaxel is part of a regimen containing other drugs, the following conditions must be met:

    1. Paclitaxel will be the first chemotherapy regimen to be infused when patient comes in for treatment
    2. Chemotherapy regimen that would be approved for the study are the following:

    i. Paclitaxel/ Carboplatin ii. Paclitaxel/Carboplatin/Bevacizumab iii. Paclitaxel/Cisplatin/Bevacizumab iv. Paclitaxel/Bevacizumab v. Paclitaxel/ Ifosfamide vi. Paclitaxel/ Pazopanib

  7. Patients should have no prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel)
  8. The chemotherapy treatment should be at one of the LLUH Adult Cancer Centers
  9. The patient should be an English or Spanish speaking patient

Exclusion Criteria:

  1. Patients who are not with the gynecologic or breast oncology service
  2. Patients who are with the gynecologic oncology or breast oncology service but are not receiving paclitaxel either as a monotherapy or in combination with other regimen
  3. Patients who have had prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel)
  4. Patients who are currently on steroid therapy and it is anticipated that therapy will not be discontinued at least a week prior to start of chemotherapy

  5. Patients with autoimmune diseases, malignancies, and any other co-morbid condition that might require steroid therapy during chemotherapy. This includes, but not limited to:

    1. Crohn's disease
    2. Immune thrombocytopenia
    3. Lupus nephritis
    4. Multiple sclerosis
    5. Primary brain tumors
    6. Multiple Myeloma
    7. Hodgkin's Lymphoma
  6. Patients with uncontrolled diabetes or diabetic or pre-diabetic patients with baseline A1C levels > 8.5
  7. Patients who are allergic to diphenhydramine and/or dexamethasone
  8. Non-English and Non-Spanish speaking patients

Sites / Locations

  • Loma Linda University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional

Short-Course

Combined

Arm Description

Oral dexamethasone (20 mg) at home, 12 hours and 6 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Oral dexamethasone (20 mg) at home, 12 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an additional intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Outcomes

Primary Outcome Measures

Least incidence of any-grade-paclitaxel-HSR first cycle
The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the first cycle of chemotherapy treatment

Secondary Outcome Measures

Least incidence of any-grade-paclitaxel-HSR in the first and second cycles
The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the first and second cycles of chemotherapy treatment
Least incidence of grade 3 or more paclitaxel-HSR in the first and second cycles
The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the first and second cycles of chemotherapy treatment
Least incidence of any-grade-paclitaxel-HSR second cycle
The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the second cycle of chemotherapy treatment
Least incidence of grade 3 or more paclitaxel-HSR first cycle
The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the first cycle of chemotherapy treatment
Least incidence of grade 3 or more paclitaxel-HSR second cycle
The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the second cycle of chemotherapy treatment

Full Information

First Posted
July 16, 2018
Last Updated
June 7, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03598426
Brief Title
Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity
Official Title
Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Breast and Gynecologic Oncology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a single center, prospective, randomized, open-label study aimed at determining the most effective means of preventing hypersensitivity reactions in gynecologic oncology patients receiving paclitaxel infusions. The study will therefore provide clinicians with the best ways of preventing paclitaxel hypersensitivity reactions in their patients during treatment. Subjects will be randomized using the block randomization method into one of these three commonly used treatment methods:(1) Conventional method: oral dexamethasone (20 mg), taking 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of histamine-1 (H1), and a histamine-2 (H2)receptor antagonists administered 30 minutes prior to paclitaxel infusion. (2) Short-course method: intravenous dexamethasone (20 mg), administered concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion. (3) Combined method: oral dexamethasone (20 mg), taking 12 hours prior to treatment in addition to intravenous dexamethasone (20 mg), H1 and H2 receptor antagonists administered 30 minutes prior to paclitaxel infusion. The one-way analysis of variance (ANOVA) would be used to determine if there is any significant difference between the different strategies that are used to pre-medicate patients prior to paclitaxel infusion. P-values of less than 0.05 will be considered statistically significant.
Detailed Description
One of the potentially serious and dose-limiting toxicities of paclitaxel is the development of hypersensitivity reactions (HSRs). Up to 42% of patients receiving paclitaxel experience an HSR, with serious (> grade 3) reactions observed in about 2% of patients. Paclitaxel prescribing information and many other references therefore strongly recommend pre-medicating patients who are to be treated with paclitaxel-containing regimen with a corticosteroid, a histamine-1 (H1), and a histamine-2 (H2) antagonist prior to paclitaxel infusion. This is done to help prevent or minimize the occurrence of HSRs that could be caused by treating patients with paclitaxel. However, the method and timing of administering these pre-medications (particularly in the case of dexamethasone) have not been standardized. The current and most commonly used methods of preventing paclitaxel HSR includes one of the following: 1. Administering oral dexamethasone (20 mg), 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of H1 and H2 receptor antagonists 30 minutes prior to paclitaxel infusion (Conventional method); 2. Administering intravenous dexamethasone (20 mg), concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion (Short-course method); 3. Administering oral dexamethasone (20 mg), 12 hours prior to treatment in addition to intravenous dexamethasone (20 mg), H1 and H2 receptor antagonists administered 30 minutes prior to paclitaxel infusion. The goal of this study is to do a single center, prospective, randomized, open-label study to determine the most effective method in preventing paclitaxel HSR among these three commonly used methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity Reactions

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Single center, prospective, randomized, open-label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Oral dexamethasone (20 mg) at home, 12 hours and 6 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.
Arm Title
Short-Course
Arm Type
Active Comparator
Arm Description
Intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.
Arm Title
Combined
Arm Type
Active Comparator
Arm Description
Oral dexamethasone (20 mg) at home, 12 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an additional intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Conventional arm will only use oral dexamethasone as intervention; Short-Course arm will only use intravenous dexamethasone as intervention; Combined arm will use both oral and intravenous dexamethasone as intervention
Primary Outcome Measure Information:
Title
Least incidence of any-grade-paclitaxel-HSR first cycle
Description
The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the first cycle of chemotherapy treatment
Time Frame
1 to 3 HOURS
Secondary Outcome Measure Information:
Title
Least incidence of any-grade-paclitaxel-HSR in the first and second cycles
Description
The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the first and second cycles of chemotherapy treatment
Time Frame
1 to 3 HOURS
Title
Least incidence of grade 3 or more paclitaxel-HSR in the first and second cycles
Description
The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the first and second cycles of chemotherapy treatment
Time Frame
1 to 3 HOURS
Title
Least incidence of any-grade-paclitaxel-HSR second cycle
Description
The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the second cycle of chemotherapy treatment
Time Frame
1 to 3 HOURS
Title
Least incidence of grade 3 or more paclitaxel-HSR first cycle
Description
The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the first cycle of chemotherapy treatment
Time Frame
1 to 3 HOURS
Title
Least incidence of grade 3 or more paclitaxel-HSR second cycle
Description
The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the second cycle of chemotherapy treatment
Time Frame
1 to 3 HOURS

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female only
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult female patients > 18 years of age Patients of the Loma Linda University Health (LLUH) gynecologic oncology and breast oncology service Confirmed breast or gynecologic cancer diagnosis of any stage and any gynecologic or breast malignancy Planned treatment with paclitaxel containing regimen either in the adjuvant setting or for palliation Planned treatment with paclitaxel should be for 3 or more cycles given as a weekly or every 3 weeks cycle Paclitaxel should be given as a monotherapy or as part of a combination regimen. If paclitaxel is part of a regimen containing other drugs, the following conditions must be met: Paclitaxel will be the first chemotherapy regimen to be infused when patient comes in for treatment Chemotherapy regimen that would be approved for the study are the following: i. Paclitaxel/ Carboplatin ii. Paclitaxel/Carboplatin/Bevacizumab iii. Paclitaxel/Cisplatin/Bevacizumab iv. Paclitaxel/Bevacizumab v. Paclitaxel/ Ifosfamide vi. Paclitaxel/ Pazopanib Patients should have no prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel) The chemotherapy treatment should be at one of the LLUH Adult Cancer Centers The patient should be an English or Spanish speaking patient Exclusion Criteria: Patients who are not with the gynecologic or breast oncology service Patients who are with the gynecologic oncology or breast oncology service but are not receiving paclitaxel either as a monotherapy or in combination with other regimen Patients who have had prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel) Patients who are currently on steroid therapy and it is anticipated that therapy will not be discontinued at least a week prior to start of chemotherapy Patients with autoimmune diseases, malignancies, and any other co-morbid condition that might require steroid therapy during chemotherapy. This includes, but not limited to: Crohn's disease Immune thrombocytopenia Lupus nephritis Multiple sclerosis Primary brain tumors Multiple Myeloma Hodgkin's Lymphoma Patients with uncontrolled diabetes or diabetic or pre-diabetic patients with baseline A1C levels > 8.5 Patients who are allergic to diphenhydramine and/or dexamethasone Non-English and Non-Spanish speaking patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kofi Donkor, PharmD
Phone
909-558-4000
Ext
15039
Email
kndonkor@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Hong, MD
Phone
909-558-4000
Ext
15504
Email
lihong@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Hong, MD
Organizational Affiliation
Loma Linda University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Hong, MD
Phone
909-558-4000
Ext
15504
Email
lihong@llu.edu
First Name & Middle Initial & Last Name & Degree
Kofi Donkor, PharmD
Phone
909-558-4000
Ext
15039
Email
kndonkor@llu.edu
First Name & Middle Initial & Last Name & Degree
Julie Selim, PharmD
First Name & Middle Initial & Last Name & Degree
Yevgeniya Ioffe, MD
First Name & Middle Initial & Last Name & Degree
Mazdak Momeni, MD
First Name & Middle Initial & Last Name & Degree
Kofi Donkor, PharmD
First Name & Middle Initial & Last Name & Degree
Gayathri Nagaraj, MD

12. IPD Sharing Statement

Learn more about this trial

Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity

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