CycloME

CycloME is a clinical trial sponsored by the ME/CFS research group at the Department of Oncology and Medical Physics at Haukeland University Hospital, Bergen, Norway. Senior Consultant Øystein Fluge and Professor Olav Mella are the study supervisors. Kari Sørland, a nurse, is the national project coordinator. The Kavli Trust, a humanitarian foundation, is contributing to the trial by funding 50 per cent of a nursing post for 12 months.

Cyclophosphamide, a chemotherapy and immunosuppressant drug, is being investigated as a treatment in ME/CFS. As with the rituximab studies, the potential efficacy with ME was stumbled on by accident after treating two breast cancer patients, who also had ME, with cyclophosphamide, and having the women report that their ME symptoms improved. Before treatment, a bedbound ME patient walked an average of 326 steps per day. After six infusions with cyclophosphamide, she was able to walk 13,000 steps daily.

CycloME part A​
The cyclophosphamide trial is a single centre, unblinded study with 40 patients with moderate to severe ME. All study participants have been chosen and treatments have started. Some of the participants are either non-responders when they were treated with Rituximab or were patients who relapsed after treatment with Rituximab. The Department of Oncology at Haukeland University Hospital is responsible for assessing which patients to include the trial, as well as administering the treatments. The Norwegian Radium Hospital, Oslo, is taking part in the trial as a treatment centre, administering treatments to a small group of patients who reside in the Oslo area. The Canadian Consensus Criteria was used in selecting participants. All participants will receive six intravenous treatments of cycophosphamide, each treatment four weeks apart. The participants will be followed-up for one year. Each will be given complete physical examinations and testing before and after treatment, and each will submit regular reports on any changes in symptoms and physical function. The physical function testing will include a measurement of activity via a Sensewear armband, a two-day Cardiopulmonary exercise tests for those who are able, and self-reporting fatigue scores. Adverse effects will be tested for with physical examinations and laboratory tests. Side effects are expected to be minimal, because similar dosages have already been used in breast cancer and lymphoma trials. The last participant will complete treatment in June 2016. Study results will be published in 2017. Data analysis with include comparing the group who recieved rituximab prior to those who did not.

CycloME part B
The Haukeland University Hospital ME/CFS research group is prepared that if the interim results from CycloME part A show a positive improvement in symptoms in a minimum of 40% of the patients, the trial may be extended to include patients with very severe ME. In part B, both treatment and follow-up will be completed in collaboration with the patient’s local primary health service. If the results from CycloME part A are negative, or fewer than 40% of the participants have a positive response, part B will not be implemented. An investigator meeting planned in September 2016 will look at preliminary data for the efficacy, as well as any toxicity of part A of the study, and assess the feasibility of continuing on with CycloME part B.

Learn More

 * CycloME website
 * 2004 Bergen, Norway outbreak
 * RituxME
 * Rituximab