[FG] Briel Matthias

Abstract

Background:

Palliative care aims to alleviate suffering, improve quality of life, and address distressing symptoms in people with advanced disease. Despite its clinical importance, many interventions—particularly pharmacological approaches—are supported by limited high-quality evidence, with recommendations often relying on expert consensus or long-standing routine. Clinical trials are essential to strengthen the evidence base, yet research in palliative care faces well-described barriers such as recruitment challenges, underpowered studies, and premature termination. To our knowledge, no meta-research study has systematically mapped the clinical-trial landscape in palliative care. This review intends to establish a benchmark for research activity, identify under-represented areas, and outline priorities for future investigation, including recruitment expectations and attrition estimates.

Objectives:

This systematic review provides a comprehensive overview of clinical trials conducted in palliative care over the past two decades. We aim to (1) quantify the number, scope, and characteristics of registered and published trials; (2) identify which symptoms and interventions are studied more intensively, and compare this with the known prevalence of symptoms in advanced disease; and (3) document rates and reasons for non-completion or non-publication of registered studies.

Methods:

We will search major trial registries (ClinicalTrials.gov, WHO ICTRP, EudraCT) and bibliographic databases for interventional studies in adult palliative-care populations registered between 2000 and 2020. Eligible studies include prospective interventional designs; pediatric studies and disease-modifying cancer therapies will be excluded. Two reviewers will independently screen records and extract data using piloted forms. Discrepancies between registered and published outcomes will be assessed, and reasons for non-publication will be sought by contacting investigators. Descriptive statistics will summarize study characteristics, with subgroup analyses by symptom category, intervention type, sponsor, and region. Meta-analysis of publication rates will be conducted if appropriate.

An international collaboration of methodologists and health researchers to optimize the development process, trustworthiness and usefulness of methods guidance. Start: Feburary 2025

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).

INPUT is a nationwide survey of people taking part in clinical trials (INPUT survey). This project is funded by the Federal Office of Public Health. The aim is to find out which experiences trial participants make. The findings from the survey can be used to review and improve legal regulations and their recommendations for implementation of human research in the interests of study participants.