This study is looking at pain management in patients with cancer who experience severe sudden pain, also called breakthrough pain, despite being on regular strong pain medication. The study will use fentanyl given as a nasal spray, which is a powerful pain relief medicine. Two forms of fentanyl will be used in the study: Fentanyl Kalceks and Fentanyl Sandoz, both given through the nose as a spray instead of by injection as they are normally used.
The purpose of the study is to collect information through questionnaires about how well fentanyl nasal spray works and how safe it is for treating breakthrough pain in cancer patients. The study is designed for adults over 18 years old who have cancer and are already taking major opioid therapy, which means they are already using strong pain medicines regularly. Patients need to be able to think clearly, use the nasal spray by themselves, and have a breathing rate above 10 breaths per minute. The study will not include patients who are pregnant or breastfeeding, have cancerous tumors in the mouth or nose, or have a known allergy to fentanyl.
During the study, patients will use the fentanyl nasal spray when they have episodes of severe sudden pain and will answer questions about how well it relieves their pain. The study will measure success by looking at the responder rate using a pain rating scale called NPRS, which helps track how much the pain improves after using the spray. The treatment period for each patient can last up to 6 months, and the entire study is expected to continue until March 2026.
Hungary 