PD Dr. med. Dr. phil. Benjamin Kasenda

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/

The Department of Medical Oncology at the University Hospital Basel, a leading oncology center in Switzerland, is addressing the complexity of clinical decision-making in cancer care, exacerbated by rapid advancements in tumor biology and treatment strategies. The integration of modern information technologies is seen as critical in transforming practices into learning health care systems (LHS), which continuously improve through data analysis and knowledge integration.

This registry aims to analyze the patterns of diagnoses, treatment recommendations, and patient outcomes to inform and enhance clinical decision-making and care quality. Specific endpoints include the frequency and proportion of cancer diagnoses and stages, types of diagnostics and treatments recommended by multidisciplinary tumor boards, treatment protocols, and patient-reported outcomes (PROMs), including quality of life, symptom management, and survival rates.

This observational cohort study collects both retrospective and prospective data from patients seen at the Medical Oncology unit between January 1, 2022, and December 31, 2025. It includes all patients meeting the inclusion criteria of having a diagnosis of malignant disease, an encounter within the specified date range, and aged 18 years or older.

Data will be gathered from existing clinical information systems such as ISMED, Clinical Dashboard, Pathology, Radiology, and CATO, with a focus on achieving high standardization using oncotree codes for diagnoses and SNOMED CT for clinical details.

The registry will use a combination of descriptive statistics to summarize patient demographics, disease characteristics, and treatments. Time-to-event analyses for outcomes like survival and disease progression will be performed using Kaplan-Meier and cumulative incidence functions.

Data will be managed using RedCap software, with stringent data protection measures in place to ensure confidentiality and security. Data collection will adhere to ethical standards set by the Human Research Act (HFG) and its ordinance (HFV).

All data will be collected as part of routine clinical processes, with additional approvals by the ethics committee for future research uses. The project will adhere to data protection laws and ethical guidelines, with a focus on minimizing risks associated with de-identification.

This registry is pivotal in establishing a structured data collection framework that supports a learning health care system, aiming to enhance the quality of cancer care and education within the Department of Medical Oncology at the University Hospital Basel.

This is a trial using routinely collected health care data from an ongoing registry (AO_2023- 00091) in cancer patients with advanced solid malignancies receiving first line systemic anti- cancer treatment for advanced disease.

This trial will assess the feasibility and implementation of routine measurement of ctDNA and its association with clinical outcomes, including quality of life and survival. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent.

The feasibility target sample size is 150 patients who accepted the invitation. We have chosen to randomly invite patients to participate, because: first, current capacities are not sufficient to offer regular ctDNA measurement to all cancer patients; second, we aim to recruit an unbiased and representative sample of patients; third, we aim to conduct comparative analyses with high internal and external validity so that our results are directly and reliably transferable to a large group of future cancer patients. 

Prevention and treatment of CNS relapse remains a great unmet clinical need in the management of aggressive B-NHL. Hence, investigating novel diagnostic tests is of paramount importance to improve risk-stratification of lymphoma patients at diagnosis, as is the evaluation of novel therapeutic approaches that may prevent and / or treat CNS recurrence. Based on the highlighted evidence, the investigators hypothesize that ctDNA detected within the CSF could potentially improve the detection rate of CNS involvement and consequently improve patients' stratification and better discriminate those in need of consolidative CNS prophylaxis on a molecular basis. Similarly, the investigators postulate that CSF ctDNA could be used as a monitoring tool to assess treatment response and guide therapeutic management.