Dexamethasone Methods for Preventing Allergic Reactions to Chemotherapy

Recruiting in Palo Alto (17 mi)

Overseen by Linda Hong, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Loma Linda University

Must be taking: Dexamethasone, H1 antagonists, H2 antagonists

Must not be taking: Steroid therapy

Disqualifiers: Autoimmune diseases, Uncontrolled diabetes, others

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on steroid therapy, it must be stopped at least a week before starting chemotherapy.

What data supports the effectiveness of the drug Dexamethasone in preventing allergic reactions to chemotherapy?

Research shows that Dexamethasone is effective in preventing allergic reactions to the chemotherapy drug paclitaxel, as it is used to reduce hypersensitivity reactions (allergic reactions) when given before treatment. ^{1 2 3 4 5}

Is dexamethasone safe for preventing allergic reactions to chemotherapy?

Dexamethasone is commonly used to prevent allergic reactions to chemotherapy drugs like paclitaxel, and it is generally considered safe for this purpose. It can be given either as a pill or through an IV (intravenous, meaning directly into a vein), and both methods have been studied for their safety and effectiveness. ^{1 2 5 6 7}

How does dexamethasone prevent allergic reactions to chemotherapy?

Dexamethasone is used to prevent allergic reactions to chemotherapy drugs like paclitaxel by reducing inflammation and immune responses. It can be given either as a pill or through an IV, with the timing and method of administration potentially affecting its effectiveness. ^{1 2 4 6 7}

Research Team

Linda Hong, MD

Principal Investigator

Loma Linda University Cancer Center

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 have been diagnosed with breast or gynecologic cancer at any stage.

I am scheduled for treatment with a paclitaxel-based regimen.

I am receiving paclitaxel alone or with other drugs.

Exclusion Criteria

I do not have autoimmune diseases or other conditions that need steroids during chemotherapy.

Patients who are not with the gynecologic or breast oncology service

I am under care for gynecologic or breast cancer but not receiving paclitaxel.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three pre-medication regimens to prevent paclitaxel-related hypersensitivity reactions

6 weeks

Weekly visits for paclitaxel infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)

Trial Overview 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.

Participant Groups

Group I: Short-Course Active Control 1 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: Combined Active Control 1 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: Conventional Active Control 1 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 Nearby Select from list below to view details:

Loma Linda University Cancer Center Loma Linda, CA

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Patients Recruited

267,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylaxis for paclitaxel hypersensitivity reactions. Kintzel, PE.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yanaranop, M., Chaithongwongwatthana, S.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone premedication for prophylaxis of taxane toxicities: can the doses be reduced when paclitaxel or docetaxel are given weekly? Schwartz, JR.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of aprepitant and dexamethasone combination on paclitaxel-induced hypersensitivity reaction. Yamamoto, T., Natio, M., Hara, S., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone protects against Cisplatin-induced activation of the mitochondrial apoptotic pathway in human osteosarcoma cells. Meyer, S., Eden, T., Kalirai, H.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous versus oral dexamethasone premedication in preventing Paclitaxel infusion hypersensitivity reactions in gynecological malignancies. O'Cathail, SM., Shaboodien, R., Mahmoud, S., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the effects of oral and intravenous dexamethasone premedication in the prevention of paclitaxel-induced allergic reactions. Chen, FC., Wang, LH., Zheng, XY., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prophylaxis for paclitaxel hypersensitivity reactions. [2017]

2. Australia pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Dexamethasone premedication for prophylaxis of taxane toxicities: can the doses be reduced when paclitaxel or docetaxel are given weekly? [2018]

4. Singapore pubmed.ncbi.nlm.nih.gov

The effect of aprepitant and dexamethasone combination on paclitaxel-induced hypersensitivity reaction. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone protects against Cisplatin-induced activation of the mitochondrial apoptotic pathway in human osteosarcoma cells. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Intravenous versus oral dexamethasone premedication in preventing Paclitaxel infusion hypersensitivity reactions in gynecological malignancies. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of the effects of oral and intravenous dexamethasone premedication in the prevention of paclitaxel-induced allergic reactions. [2018]