Optimisation of pain management in oncology
The NoDoubt study is investigating the efficacy of the non-opioid painkillers dipyrone (metamizole) and ibuprofen in the treatment of cancer-related pain. They are administered in addition to opioid therapy and compared with placebo.
Background
Every year, in Switzerland around 17'000 patients die of cancer. Almost half of them suffer from cancer-related pain. Guidelines recommend treating them with a combination of opioids and non-opioids (e.g. ibuprofen).
However, there is a lack of convincing academic studies in this clinical setting, meaning that the benefits of combination therapies have not been proven empirically. This leads to a disagreement among experts as to whether and, if so, which non-opioid is most suitable.
As a result, around one third of patients do not receive any non-opioid painkillers and may therefore not receive appropriate treatment. In addition, patients receiving a non-opioid treatment may not be receiving an effective medication.
Aim
The aim of this study is to investigate the effect of administering 4.0 grams of dipyrone (metamizole), 1.2 grams of ibuprofen or placebo in addition to orpoid treatment on the pain intensity of patients with moderate to severe cancer-related pain.
Study design
Multicenter, randomised, placebo-controlled superiority study
The study is characterised, among other things, by a high proportion of Patient and Public Involvement (PPI) activities in the planning and implementation. This means that patients were able to participate in the conception, design and implementation of the study.
NoDoubt study
Efficacy of non-opioid drugs in addition to opioid therapy for cancer pain management: a double-blind, randomized, threearm, placebo-controlled trial assessing the key non-opioids dipyrone (metamizole) and ibuprofen
Lead
Principal Investigator
PD Dr. med. Christopher Böhlke, University Hospital Basel
DKF Research Group Jan Gärtner
Co-Investigator
Sophie Pautex, University Hospital Geneva
Tanja Fusi-Schmidhauser, Clinica Di Cure Palliative E Di Supporto Eoc
Tobias Schneider, University Hospital Basel
Marcus Vetter, Canton of Baselland Cantonal Hospital
Study design
Multicenter, randomised, placebo-controlled superiority study
Study centers
5 centers in Switzerland
Number of planned study participants
309
Project duration
5 years
DKF support
Methodological counsulting, Regulatory Affairs, Statistics, Data Management, Monitoring, On Site Management, Project Management, Quality Management, Patient & Public Involvement
Funding
SNSF IICT, Call 2024
What is the most effective treatment for cancer-related pain?
Significance of the study
This study aims to find answers to a pending research question in which the pharmaceutical industry is not interested. It aims to clarify whether the addition of non-opioid painkillers to opiod treatment is beneficial for patients with cancer-related pain. Clarification of this question may prevent ineffective treatments or overtreatment in the future.
Project partners
Sacha Rothschild, Cantonal Hospital Baden
Sandra Eckstein, Viola Heinzelmann, Benjamin Kasenda, Frank Zimmermann, University Hospital Basel