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

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ClinicalTrials.gov Identifier: NCT03598426
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Linda Hong, MD, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Hypersensitivity Reactions Drug: Dexamethasone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, prospective, randomized, open-label study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Gynecologic Oncology Patients: A Prospective, Randomized, Open-label Study
Estimated Study Start Date : September 28, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Conventional
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.
Drug: Dexamethasone
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
Other Name: Decadron

Active Comparator: Short-Course
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.
Drug: Dexamethasone
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
Other Name: Decadron

Active Comparator: Combined
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.
Drug: Dexamethasone
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
Other Name: Decadron




Primary Outcome Measures :
  1. Least incidence of any-grade-paclitaxel-HSR first cycle [ Time Frame: 1 to 3 HOURS ]
    The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the first cycle of chemotherapy treatment


Secondary Outcome Measures :
  1. Least incidence of any-grade-paclitaxel-HSR in the first and second cycles [ Time Frame: 1 to 3 HOURS ]
    The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the first and second cycles of chemotherapy treatment

  2. Least incidence of grade 3 or more paclitaxel-HSR in the first and second cycles [ Time Frame: 1 to 3 HOURS ]
    The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the first and second cycles of chemotherapy treatment

  3. Least incidence of any-grade-paclitaxel-HSR second cycle [ Time Frame: 1 to 3 HOURS ]
    The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the second cycle of chemotherapy treatment

  4. Least incidence of grade 3 or more paclitaxel-HSR first cycle [ Time Frame: 1 to 3 HOURS ]
    The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the first cycle of chemotherapy treatment

  5. Least incidence of grade 3 or more paclitaxel-HSR second cycle [ Time Frame: 1 to 3 HOURS ]
    The treatment group that had the least incidence of grade 3 or more paclitaxel-HSR in the second cycle of chemotherapy treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female only
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult female patients > 18 years of age
  2. Patients of the Loma Linda University Health (LLUH) gynecologic oncology service
  3. Confirmed gynecologic cancer diagnosis of any stage and any gynecologic 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 oncology service
  2. Patients who are with the gynecologic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598426


Contacts
Contact: Kofi Donkor, PharmD 909-558-4000 ext 15039 kndonkor@llu.edu
Contact: Linda Hong, MD 909-558-4000 ext 15504 lihong@llu.edu

Locations
United States, California
Loma Linda University Cancer Center Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Linda Hong, MD    909-558-4000 ext 15504    lihong@llu.edu   
Contact: Kofi Donkor, PharmD    909-558-4000 ext 15039    kndonkor@llu.edu   
Sub-Investigator: Julie Selim, PharmD         
Sub-Investigator: Yevgeniya Ioffe, MD         
Sub-Investigator: Mazdak Momeni, MD         
Sub-Investigator: Kofi Donkor, PharmD         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Linda Hong, MD Loma Linda University Cancer Center

Responsible Party: Linda Hong, MD, Primary Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT03598426     History of Changes
Other Study ID Numbers: 5180198
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Dexamethasone
Dexamethasone acetate
BB 1101
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors