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 initital treatment and follow-up phases were completed in August 2017. In order to collect more data on long-term benefits and toxicity, the study was extended with follow-up at two additional time points.
The results from part A of the CycloME trial have been submitted for publishing.