A randomized, open-label, phase III trial evaluating dexamethasone-free anti-emetic regimen versus standard dexamethasone-containing regimen in patients receiving multi-day highly emetogenic chemotherapy (DEXA-FREE).

This study is looking at how to better prevent nausea and vomiting in cancer patients who are getting chemotherapy over multiple days. These side effects, called chemotherapy-induced nausea and vomiting (CINV), are common and can seriously affect a patient’s comfort and quality of life.

Right now, most patients are given a steroid medicine called dexamethasone along with other anti-nausea drugs. Dexamethasone is effective but can cause side effects, especially when used for several days. These side effects may include high blood sugar, sleep problems, mood changes, infections, and high blood pressure.

A recent study in patients getting chemotherapy for one day showed that removing dexamethasone from the anti-nausea treatment did not reduce its effectiveness and led to fewer side effects. This new study wants to see if the same approach works for people receiving chemotherapy over multiple days.

The study will compare two groups of patients:

1.One group will get the standard anti-nausea treatment (which includes dexamethasone)

2. The other group will get a steroid-free anti-nausea treatment, which includes:

a. Olanzapine (used in low doses to reduce nausea),

b. A 5-HT3 blocker like palonosetron, ondansetron, or granisetron,

c. An NK-1 blocker like aprepitant or fosaprepitant.

If the steroid-free treatment works just as well, patients could avoid the unpleasant side effects of steroids, feel better during treatment, and have an improved quality of life. The main goal is to see how well the treatments prevent vomiting during the full course of chemotherapy. Other things the researchers will check include:

1. How much nausea patients feel,

2. How safe and tolerable the treatments are,

3.How the treatments affect daily life and satisfaction,

4.Whether patients needed extra medicine for nausea.

Adults between 18 and 70 years old who are about to start multi-day chemotherapy for cancer and have not received chemotherapy before. People who recently took certain medications, have uncontrolled illnesses, or have conditions like brain metastases or severe stomach problems may not be eligible. Participation is voluntary. Before joining, each patient will be fully informed about the study and asked to sign a consent form. The process will follow all ethical and regulatory guidelines to ensure the patient’s rights and safety.