The Cyclophosphamide trial is a single centre study. The Dept. of Oncology at Haukeland University Hospital was the only study centre assessing and including patients in the trial. In addition, the Norwegian Radium Hospital took part in the trial as a treatment centre, administering treatments to a small group of patients resident in the Oslo area.
The CycloME trial is an unblinded study, which means all participants have received treatment with the active substance. Each patient received six intravenous treatments four weeks apart, and follow-up for one year after treatment. The participants completed examinations and tests before and after treatment, and they submitted regular reports on any changes in symptoms and physical function.
The purpose of the study was to investigate the effects and side effects of cyclophosphamide in a group of patients suffering from ME/CFS.
40 patients with moderate to severe ME participated in the trial.
Status, CycloME part A
The treatment and follow-up phases were completed in August 2017.
Analyses of the overall results indicate that there is reason to pursue further testing of cyclophosphamide treatment in ME/CFS. We have therefore decided to move on with an amended protocol for part B of the study.
We aim to publish the results from part A of the CycloME trial during 2018.