Comparing oral and intravenous dexamethasone for preventing hypersensitivity to paclitaxel
Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Breast and Gynecologic Oncology Patients
This study is testing whether taking dexamethasone by mouth, through an IV, or a mix of both can better prevent allergic reactions in women receiving paclitaxel for cancer treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Loma Linda University Academic / other |
| Drugs / interventions | Bevacizumab, chemotherapy |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT03598426 on ClinicalTrials.gov |
What this trial studies
This study is a single-center, prospective, randomized, open-label investigation aimed at identifying the most effective method for preventing hypersensitivity reactions in gynecologic oncology patients receiving paclitaxel infusions. Participants will be randomly assigned to one of three treatment groups: conventional oral dexamethasone, short-course intravenous dexamethasone, or a combined approach. The study seeks to standardize pre-medication protocols to minimize the risk of hypersensitivity reactions during paclitaxel treatment. By evaluating the efficacy of these methods, the study aims to provide clinicians with evidence-based guidelines for managing paclitaxel hypersensitivity.
Who should consider this trial
Good fit: Ideal candidates include adult female patients over 18 years with a confirmed diagnosis of breast or gynecologic cancer who are scheduled to receive paclitaxel.
Not a fit: Patients who are not receiving paclitaxel or those with contraindications to dexamethasone will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of hypersensitivity reactions in patients undergoing paclitaxel treatment.
How similar studies have performed: Previous studies have explored various pre-medication strategies for paclitaxel, but this specific comparison of oral versus intravenous dexamethasone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Loma Linda, California
- Loma Linda University Cancer Center — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Linda Hong, MD — Loma Linda University Cancer Center
- Study coordinator: Kofi Donkor, PharmD
- Email: kndonkor@llu.edu
- Phone: 909-558-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.