Study on the Effects of Removing Dexamethasone from Premedication in Paclitaxel Treatment for Patients with Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of omitting dexamethasone in premedication regimens for patients undergoing treatment with paclitaxel, a common chemotherapy drug used to treat solid tumors. The study will compare the standard premedication regimen, which includes dexamethasone, with an experimental regimen that does not include dexamethasone. Dexamethasone is a medication often used to prevent allergic reactions and inflammation during chemotherapy.

The purpose of the study is to evaluate the occurrence of significant allergic reactions, known as hypersensitivity reactions, during paclitaxel treatment. Participants will receive either the standard premedication with dexamethasone or the experimental regimen without it. The study will monitor the percentage of patients who experience these reactions and assess the severity of any reactions that occur. Additionally, the study will look at the impact of dexamethasone on patients’ quality of life and any side effects related to its use.

The trial will take place over a period of time, with participants being closely monitored by medical staff. The study aims to provide valuable information on whether dexamethasone can be safely omitted from premedication regimens without increasing the risk of allergic reactions during paclitaxel treatment. This research could potentially lead to changes in how premedication is administered to patients with solid tumors undergoing chemotherapy.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), diagnosis of a solid tumor, and planned treatment with paclitaxel-based chemotherapy.

Written informed consent is required to participate.

2 treatment preparation

The study evaluates the omission of dexamethasone in premedication regimens during paclitaxel treatment.

Participants are divided into two groups: one receiving the standard premedication regimen with dexamethasone and the other without it.

3 medication administration

For those in the standard regimen group, dexamethasone is administered either orally as 4 mg tablets or intravenously as a 4 mg/ml solution for injection.

The frequency and duration of dexamethasone administration are determined by the oncology medical staff.

4 paclitaxel infusion

Participants receive paclitaxel-based chemotherapy.

The primary focus is to monitor the occurrence of hypersensitivity reactions (HSRs) during the infusion.

5 monitoring and evaluation

The primary outcome is the percentage of patients experiencing clinically relevant HSRs during paclitaxel infusion.

Secondary outcomes include the incidence and severity of all HSRs, the possibility of rechallenge, and the number of paclitaxel administrations until the first HSR occurrence.

6 quality of life assessment

Quality of life is assessed using tools like the EuroQol-5 dimensions-5 levels (EQ-5D-5L) and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30).

7 study completion

The study is estimated to end by January 1, 2027.

The total cost of treatment for both premedication regimens is evaluated from a healthcare and societal perspective.

Who Can Join the Study?

You must be at least 18 years old.
You need to have a solid tumor, which is a type of cancer that forms in solid organs or tissues, and you should be planning to receive treatment with paclitaxel-based chemotherapy. Paclitaxel is a medication used to treat cancer.
You should be able to speak and understand the Dutch language.
You must be able and willing to provide written informed consent, which means you agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

Patients who have had a severe allergic reaction, known as a hypersensitivity reaction, to paclitaxel or similar drugs in the past.
Patients who are currently taking medications that might interfere with the study treatment.
Patients with certain medical conditions that could make participation unsafe, as determined by the study doctor.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within a certain time frame before this study.
Patients who have a history of certain heart conditions that could be worsened by the study treatment.
Patients who have an active infection that requires treatment.
Patients who have a history of other cancers, unless they have been in remission for a certain period.
Patients who have a known allergy to any of the ingredients used in the study treatment.
Patients who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Groene Hart Ziekenhuis	Gouda	The Netherlands
Amphia Hospital	Breda	The Netherlands
Alrijne Zorggroep Stichting	Leiderdorp	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Emfpaqp Usdgstbhujpv Mrnnyns Cwijqmm Rbqbptqds (ewgrdws Myy	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.02.2024

Trial locations

Investigated drugs:

Paclitaxel is a chemotherapy medication used to treat various types of cancer. In this trial, it is being used to evaluate the effects of different premedication regimens on the incidence of hypersensitivity reactions during treatment.

Dexamethasone is a corticosteroid medication often used to prevent allergic reactions and inflammation. In this study, it is part of the standard premedication regimen given before paclitaxel treatment. The trial aims to assess the effects of omitting dexamethasone from the premedication regimen.

Investigated diseases:

Neoplasm

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are classified based on the type of cells they originate from, such as sarcomas, carcinomas, and lymphomas. Solid tumors can grow and spread to other parts of the body, a process known as metastasis. The progression of solid tumors can vary widely depending on their location, size, and the specific type of cells involved. They may cause symptoms by pressing on nearby organs or tissues, leading to pain or dysfunction.

Trial ID:

2023-507481-43-00

NCT ID:

NCT06118710

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Removing Dexamethasone from Premedication in Paclitaxel Treatment for Patients with Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?