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Efficacy of non-opioid drugs in addition to opioid therapy for cancer pain management: a double-blind, randomized, three arm, placebo controlled trial assessing the key non-opioids dipyrone (metamizole) and ibuprofen: NoDoubt-trial

Research Project  | 11 Project Members

Background

Cancer-related pain is among the most prevalent and distressing symptoms experienced by patients, significantly contributing to their overall suffering. Due to limited supporting evidence for many pharmacological therapies, patients may not receive potentially effective pain management.

Rationale

The potential benefit of adding non-opioid analgesics to opioid therapy in cancer pain management—such as improved symptom control or reduced opioid dosage—remains unproven, though recommended by guidelines from WHO, ASCO, and ESMO. The efficacy evidence for widely used non-opioid analgesics, specifically dipyrone (metamizole) and ibuprofen, when combined with opioids, is extremely limited, leaving many patients untreated or receiving suboptimal therapy. Safety concerns further complicate the use of both dipyrone and ibuprofen. Paracetamol (acetaminophen), another widely used non-opioid, has been examined in multiple randomized controlled trials (RCTs) showing a lack of efficacy as an adjunct to opioids; thus, it is excluded from this trial.

Aims/Methodology

This multicenter, randomized, double-blind, placebo-controlled, three-armed superiority trial assess the efficacy of dipyrone and ibuprofen, when used alongside opioids, compared to a placebo, for managing cancer-related pain.

Relevance to patients and current treatment guidelines

This study holds critical relevance for patients and clinical practice. First, combining non-opioid analgesics with opioids in cancer pain management is practiced by some clinicians, though limited evidence on its efficacy results in many patients either not receiving adjunct non-opioids or receiving suboptimal choices. Second, our research directly aligns with priorities identified by the James Lind Alliance, focusing on reducing cancer pain while minimizing reliance on opioids, which often cause undesirable side effects. Using non-opioid analgesics in combination with opioids may lower the opioid dosage required for effective pain control. Third, many cancer studies exclude patients with low performance status, though they experience the highest symptom burden. Due to this evidence gap, thousands of cancer patients in Switzerland and internationally may not receive optimal pharmaceutical care despite potential benefits and clear need. Members of the Association for Palliative Medicine of Great Britain and Ireland, for instance, recently called for such a study. Our study’s results will directly impact and promptly inform current treatment guidelines, as the lead investigators are part of the national guideline development team.

Public Patient Involvment: https://dkf.unibas.ch/de/aktuell/ppi-in-der-nodoubt-studie/

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Evaluation of age-related tolerance of double J ureteric stents in children: a multicenter prospective observational study

Research Project  | 2 Project Members

Double-J-stents (DJS) are a common tool in urology and are used for stenting the ureter between the kidney and the bladder. They are applied for various reasons, including the reduction of risk for postoperative strictures and urinary leakage into the abdominal cavity. In Paediatric urology, DJS are mostly inserted after pyeloplasty and ureteral reimplantation. Depending on the underlying condition, DJS remain in place from a few weeks to several months. Indwelling DJS cause irritative symptoms in up to 80% of adult patients, thereby decreasing their quality of life (QoL). Patients often report voiding problems such as urgency or radiating pain in the suprapubic region, flanks, or genitalia[4]. In 2003, a Ureteral Stent Symptom Questionnaire (USSQ) was developed for adults, which assesses the morbidity caused by DJS. Since its development, the USSQ has been an established tool for evaluating the stent-related quality of life in adults.

In paediatric urology, neither a comparable questionnaire exists nor have stent-related irritative symptoms been adequately studied yet. There is no standardised method to assess different stent designs and drugs to reduce stent-related irritation.

This study aims to evaluate a novel age-adapted questionnaire to assess the tolerance of ureteric DJS in children, adapted from the USSQ. Furthermore, our goal was to evaluate irritative and other symptoms in children following DJS insertion using this novel questionnaire.

The results of our study could enable us to tailor therapy for each patient based on their individual risk of experiencing discomfort or complications associated with a ureteral stent. By optimizing the therapy, we aim to prevent premature stent removal, ensuring it remains in place for the full duration necessary for the patient’s treatment.

 

 

 


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CANTO - Cell-free DNA in acute Stroke

Research Project  | 6 Project Members

Hintergrund: Die zellfreie DNA (cfDNA) ist ein pro-inflammatorischer und pro-thrombotischer Mediator im akuten ischämischem Hirnschlag. CfDNA wird von sterbenden Gehirnzellen freigesetzt und ist auch wichtiger ein Bestandteil von „neutrophil extracellular traps“ (NETs) und damit in die Immunothrombose involviert. Die genaue Herkunft von cfDNA und ihre Bedeutung für die Ätiologie und Therapie des Hirnschlags sind jedoch unklar.

Ziel: Die CANTO-Studie untersucht cfDNA im akuten Stadium des Hirnschlags durch kombinierte Blut- und Thrombusanalysen. Ziel ist es, cfDNA in verschiedenen Schlaganfallätiologien sowie in Bezug auf sekundäre Embolien und die Reperfusionswahrscheinlichkeit zu analysieren.

Methodik: In einer prospektiven Kohortenstudie werden Patienten mit akutem ischämischem Hirnschlag untersucht, die einer mechanischen Thrombektomie unterzogen werden. Blutproben werden vor dem Eingriff entnommen, Thromben schockgefroren und mittels Nanopore-Sequenzierung analysiert. Ein 90-Tage-Follow-up wird durchgeführt.

Bedeutung: CANTO wird neue Erkenntnisse zur Rolle von cfDNA im Hirnschlag liefern und damit potentiell neue diagnostische und therapeutische Ansätze ermöglichen.