Dexamethasone Methods for Preventing Allergic Reactions to Chemotherapy
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Loma Linda University
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests three different ways to prevent allergic reactions in women with gynecologic cancers who are treated with paclitaxel. The methods involve using steroids and antihistamines before the treatment. The goal is to find out which method works best to keep patients safe from allergic reactions. Paclitaxel is a plant product highly active in numerous cancers, but it has a significant incidence of hypersensitivity reactions, which are typically managed with steroids and antihistamines.
Do I have to stop taking my current medications for this trial?The trial does not specify if you need to stop all current medications, but you cannot be on steroid therapy unless it can be stopped at least a week before starting chemotherapy.
Is dexamethasone a promising drug for preventing allergic reactions to chemotherapy?Yes, dexamethasone is a promising drug for preventing allergic reactions to chemotherapy, especially when used to prevent reactions to the drug paclitaxel. It can be given either as a pill or through an IV, and it helps reduce the risk of allergic reactions during treatment.14567
What safety data exists for using dexamethasone to prevent allergic reactions to chemotherapy?Dexamethasone is commonly used to prevent hypersensitivity reactions to chemotherapy drugs like paclitaxel. Studies have evaluated both oral and intravenous forms of dexamethasone for this purpose. Research indicates that dexamethasone is effective in reducing hypersensitivity reactions, although the optimal administration method (oral vs. intravenous) is still under investigation. Side effects and efficacy have been compared in various trials, but overall, dexamethasone is considered a standard premedication to prevent allergic reactions during chemotherapy.12456
What data supports the idea that Dexamethasone Methods for Preventing Allergic Reactions to Chemotherapy is an effective drug?The available research shows that Dexamethasone is effective in preventing allergic reactions to chemotherapy drugs like paclitaxel. Studies have compared different ways of giving Dexamethasone, such as through an IV or by mouth, and found it helps reduce allergic reactions. Another study looked at using Dexamethasone with another drug, aprepitant, and found that even with a lower dose, it still helped prevent reactions. This suggests that Dexamethasone is a reliable option for managing these side effects.12357
Eligibility Criteria
This trial is for adult female patients over 18 with breast or gynecologic cancer who will receive paclitaxel as their first chemo at LLUH Cancer Centers. They must not have had taxanes before, be English or Spanish speakers, and plan to undergo at least 3 cycles of treatment with specific regimens including paclitaxel.Inclusion Criteria
I am scheduled for treatment with a paclitaxel-based regimen.
I am receiving paclitaxel alone or with other drugs.
I am scheduled for at least 3 cycles of paclitaxel treatment.
My chemotherapy is approved for this study.
Paclitaxel will be my first chemotherapy treatment.
I have never been treated with taxanes.
Exclusion Criteria
I do not have autoimmune diseases or other conditions that need steroids during chemotherapy.
I am under care for gynecologic or breast cancer but not receiving paclitaxel.
I have been treated with taxanes before.
My diabetes is not under control, or my A1C level is above 8.5.
I do not speak English or Spanish.
Treatment Details
The study compares three methods to prevent hypersensitivity reactions from paclitaxel: conventional oral dexamethasone taken twice before infusion; short-course IV dexamethasone given just before infusion; and a combined method using both oral and IV dexamethasone.
3Treatment groups
Active Control
Group I: Short-CourseActive Control1 Intervention
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.
Group II: CombinedActive Control1 Intervention
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.
Group III: ConventionalActive Control1 Intervention
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Loma Linda University Cancer CenterLoma Linda, CA
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
References
Prophylaxis for paclitaxel hypersensitivity reactions. [2017]To evaluate clinical literature supporting the prophylactic use of single-dose intravenous dexamethasone to prevent hypersensitivity reactions (HSRs) to paclitaxel infusion.
Dexamethasone protects against Cisplatin-induced activation of the mitochondrial apoptotic pathway in human osteosarcoma cells. [2020]Dexamethasone (Dx) is often used to alleviate the acute emetic toxicity associated with high dose cisplatin (cDDP) in osteosarcoma patients. However, in other tumour cell types, Dx has been reported to induce partial resistance to anticancer drugs.
Dexamethasone premedication for prophylaxis of taxane toxicities: can the doses be reduced when paclitaxel or docetaxel are given weekly? [2018]To evaluate the clinical literature supporting reduced doses of dexamethasone to prevent taxane hypersensitivity reactions (HSRs), and edema/skin toxicities in respect to docetaxel, when taxanes are given weekly, as opposed to every 3 weeks.
Intravenous versus oral dexamethasone premedication in preventing Paclitaxel infusion hypersensitivity reactions in gynecological malignancies. [2018]Dexamethasone premedication is required with paclitaxel to prevent infusion-related hypersensitivity reactions (HSRs). Both oral dexamethasone (PO-D; 20 mg 12 and 6 hours before paclitaxel) and intravenous dexamethasone (IV-D; 20 mg 30 minutes before paclitaxel) regimens are used. The optimal premedication regimen and management of patients after HSR are unclear.
Intravenous versus oral dexamethasone for prophylaxis of paclitaxel-associated hypersensitivity reaction in patients with primary ovarian, fallopian tube and peritoneal cancer: A double-blind randomized controlled trial. [2018]To compare the efficacies and side effects of intravenous and oral dexamethasone (IV-D and PO-D) for paclitaxel-associated hypersensitivity reaction (P-HSR) prophylaxis in patients with primary ovarian, fallopian tube and peritoneal carcinomas (POC/PFTC/PPC) receiving a first cycle of paclitaxel plus carboplatin (TC).
Meta-analysis of the effects of oral and intravenous dexamethasone premedication in the prevention of paclitaxel-induced allergic reactions. [2018]Dexamethasone premedication is required to prevent paclitaxel-related hypersensitivity reactions (HSRs). Oral dexamethasone (PO-D) has been considered the standard premedication regimen. However, whether intravenous dexamethasone (IV-D) is feasible for preventing paclitaxel-related HSRs is still unclear. We conducted a meta-analysis to compare these two regimens.
The effect of aprepitant and dexamethasone combination on paclitaxel-induced hypersensitivity reaction. [2020]Dexamethasone (DEX) is often administered to prevent paclitaxel (PTX)-induced hypersensitivity reactions (HSR). The DEX dose is reduced when administered in combination with aprepitant (APR). However, the influence of that dose reduction on PTX-induced HSR has not been thoroughly studied. The present authors aimed to investigate the effects of the combined administration of APR and DEX on PTX-induced HSR.