Phase II Study of a Steroid-Sparing Treatment Using Olanzapine and Palonosetron to Prevent Nausea and Vomiting from High Dose Cisplatin in Solid Tumor Cancer Patients

What this Trial Is About

This research evaluates a steroid-sparing treatment using olanzapine and palonosetron to prevent nausea and vomiting in patients receiving high dose cisplatin chemotherapy for solid tumors. The study focuses on reducing dexamethasone use while maintaining control of chemotherapy-induced nausea and vomiting. It is a phase II trial sponsored by Mahidol University aiming to improve prevention strategies for this common side effect of cancer treatment. Participants receive a regimen of olanzapine and palonosetron combined with dexamethasone given only on the first day of chemotherapy, omitting dexamethasone on days 2 to 4. This single-group study design tests this sparing approach during the first cycle of cisplatin chemotherapy at doses of at least 50 mgm2. The treatment is administered alongside standard cancer care for patients with solid tumors. During the study, participants are monitored for complete response to treatment, specifically the absence of nausea and vomiting for five days after chemotherapy. Researchers will assess nausea severity, adverse effects, and use of rescue therapies at this timepoint. The trial duration includes the initial chemotherapy cycle and a follow-up period of five days post-treatment to evaluate the outcomes and safety of the steroid-sparing regimen.

Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin