PD Dr. med. Christopher Böhlke

Background

Due to well-known sociodemographic changes and the rising prevalence of multimorbidity, the demand for palliative and end-of-life care is expected to increase significantly in the coming years. This is particularly driven by the growing incidence of frailty, dementia, and chronic, progressive, and life-limiting conditions such as heart failure, lung diseases (e.g., chronic obstructive pulmonary disease [COPD]), and multimorbidity. Digital health technologies have the potential to facilitate automated detection of distress in palliative care, including symptoms like pain, breathlessness (dyspnea), panic, agitation, and delirium. Such advancements could alleviate the suffering of cognitively impaired patients who are unable to call for help, for instance, by pressing an alarm button, yet urgently require professional intervention (e.g., administration of medication for pain or breathlessness).

Aim

This observational feasibility study aims to assess if data output from a sensor system consisting of a 3-D-radar, photoplethysmographic sensors (wearables), and audio detection (microphones) is associated with patient’s distress events as identified by medical professionals during standard care.

Research Plan

We will utilize well-established sensor systems, including Qumea® and wearables, to monitor heart rate, respiratory rate, heart rate variability, body movements, postures, and audio signals, such as changes in sound intensity or voice frequency. These data will be compared against the current gold standard for detecting distress in cognitively impaired patients: assessments conducted by trained healthcare professionals, specifically specialist palliative care nurses and physicians. Identifying correlations between sensor data and professional distress assessments could facilitate future validation studies, potentially leading to the development of automated distress detection systems using sensor arrays. This advancement would significantly improve distress detection rates and reduce patient suffering.

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.

Background:

In cancer patients with incurable disease pain is one of the most debilitating symptoms with a prevalence of about 70% (1). Many of these patients need opioids, which are the mainstay in managing cancer pain. Initiation of opioid therapy is frequently hindered by opioid induced nausea and vomiting (OINV) in up to 40% of patients (2). Nausea is highly distressing symptom that may occur with or without vomiting and can affect overall outcome and quality of life (3). To avoid discontinuation of the opioid therapy 50-80% of doctors prescribe prophylactic or on-demand antiemetics to reduce OINV (4), although evidence for this practice is scarce or not supported by randomised controlled trials (RCTs) (5). However, the medications used to prevent OINV, e.g. dopamine antagonists can trigger adverse events in the central nervous system (headaches, drowsiness) or even parkinsonism-like symptoms.

 Aims / Methods:

To better inform physicians, guidelines and patients, we propose a Cochrane systematic review and meta-analysis of RCTs concerning the benefits and harms of antiemetic drug therapy for the prevention and treatment of OINV in patients treated with opioids for cancer pain therapy.

Benefit for patients and / or public

The numbers of affected patients are expected to increase during the decades to come due to the medical progress in oncology and the demographic change (9,10).