Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain

Launched by HENAN CANCER HOSPITAL · Mar 26, 2025

Keywords

ClinConnect Summary

Cancer remains a significant health concern globally, with rising incidence and mortality rates. In 2022, there were 19.96 million new cancer cases and 9.74 million cancer deaths worldwide, including 4.8 million new cases and 2.6 million deaths in China. Cancer patients often experience pain during treatment, with 40% of patients reporting persistent pain, particularly moderate to severe pain, occurring in 40%-80% of cases. Unrelieved pain can exacerbate symptoms such as anxiety, depression, fatigue, insomnia, and loss of appetite, significantly impacting patients' quality of life. Opioids,...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old, with a histological or pathological diagnosis of advanced cancer.
• • Be diagnosed with severe (NRS ≥ 7 points) cancer pain, requiring regular opioid therapy.
• • Diagnosed with OIC according to the Rome IV diagnostic criteria for OIC, with a BFI score ≥ 30.
• • Determined by the investigator to be eligible for treatment with oxycodone/naloxone sustained-release tablets.
• • Estimated survival period of more than 3 months.
• • Voluntarily sign an informed consent form.
• Exclusion Criteria:
• • Patients with contraindications to oxycodone/naloxone sustained-release tablets (including allergy to the active ingredients or any excipients of this product; severe respiratory depression accompanied by hypoxemia and/or hypercapnia; severe chronic obstructive pulmonary disease; pulmonary heart disease; severe bronchial asthma; paralytic ileus caused by non-opioid drugs; moderate to severe liver function impairment).
• • Patients with structural malformations of the gastrointestinal tract (such as intestinal obstruction, stenosis), other known gastrointestinal diseases/symptoms (including cancer metastasis to the digestive tract), or gastrointestinal digestion and absorption disorders.
• • Patients with language communication barriers, cognitive impairments or mental illnesses, intracranial metastasis of tumors with consciousness disorders, or consciousness disorders caused by other reasons.
• • Other situations that the investigator judges as unsuitable for inclusion in the study.

Trial Officials