Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS) (CycloME)

Haukeland University Hospital

Status and phase

Completed

Phase 2

Conditions

Myalgic Encephalomyelitis (ME)

Chronic Fatigue Syndrome (CFS)

Treatments

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02444091

2014-004029-41 (EudraCT Number)

KTS-7-2015

Details and patient eligibility

About

Significant clinical improvements of ME/CFS symptoms were observed in two patients with long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for Hodgkin lymphoma.

Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks apart, in two of these with a significant clinical response.

The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total.

The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS symptoms and tolerability/side effects during 12 months follow-up will be registered, and additional tests will be performed to objectively register changes in physical ability during follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin microvascular dysfunction will be performed before start of intervention and during follow-up.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with ME/CFS according to "Canadian" criteria (2003)
Duration of ME/CFS at least 2 years
Mild/Moderate, Moderate, Moderate/Severe and Severe ME/CFS may be included
Age 18-65 years
Signed informed consent

Exclusion criteria

Patients with fatigue who do not comply by the diagnostic "Canadian" criteria (2003) for ME/CFS
Duration of ME/CFS less than 2 years
Mild ME/CFS
Very severe ME/CFS (bedridden requiring help for all tasks)
Patients where the workup uncovers other pathology as possible cause of symptoms
Pregnancy or breast feeding
Previous malignant disease (except basal cell carcinoma of skin and cervical carcinoma in situ/dysplasia)
Previous long-term systemic treatment with immunosuppressive agents (e.g. azathioprine, ciclosporin, mycophenolate mofetil). Except steroid treatment for e.g. obstructive lung disease or autoimmune diseases such as e.g. ulcerative colitis
Serious endogenous depression
Lack of ability to complete the study including follow-up
Reduced renal function (creatinine > 1.5 x UNL)
Reduced liver function (bilirubin or transaminases > 1.5 x UNL)
Known hypersensitivity to cyclophosphamide or metabolites
Reduced bone marrow function
Ongoing cystitis or urinary tract obstruction
Known HIV positivity, previous hepatitis B or hepatitis C, or reason to suspect other ongoing and clinically relevant infection