Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome

Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An open label phase-II study with 6 infusions of cyclophosphamide 4 weeks apart. - Cyclophosphamide in ME/CFS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004029-41-NO

Enrollment

Registered

2014-10-22

Start date

2015-02-09

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome/ Myalgic Encephalopathy, as defined by Canadian Consensus Criteria (2003) MedDRA version: 18.0 Level: PT Classification code 10008874 Term: Chronic fatigue syndrome System Organ Class: 10018065 - General disorders and administration site conditions

Interventions

Trade Name: Sendoxan Pharmaceutical Form: Concentrate and solvent for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with chronic fatigue syndrome according to Canadian inclusion criteria (2003). -Duration of disease at least 24 months. -Severe, moderate/severe, moderate and moderate/mild ME/CFS may be included. -Age 18-65 years. -Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Patients with fatigue, who do not comply with the diagnostic (”Canadian”) criteria for ME/CFS. -Disease duration 1,5 x reference area). -Reduced liver function (bilirubin > 1,5 x reference area, or transaminase > 1,5 x reference area). -Known HIV-positivity, previous hepatitis B or hepatitis C, or reason to suspect other ongoing and clinically relevant infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this trial is to evaluate the efficacy, toxicity and feasibility of six infusions cyclophosphamide given four weeks apart, for patients with chronic fatigue syndrome (ME/CFS).;Secondary Objective: see secondary endpoints;Primary end point(s): The primary endpoint is recorded from the patient self-report form completed every two weeks during a follow-up period of 12 months after the first treatment. The variable Fatigue score is calculated every two weeks as the mean (scale 0-6) of the four symptoms: Fatigue, Post-exertional malaise, Need for rest and Daily function. The primary endpoint will be change in self-reported Fatigue score from baseline to mean scores during specific time intervals in the follow-up period (0-3, 3-6, 6-9 and 9-12 months), expressing the effect on the ME/CFS symptoms. The Overall Response records the effect on the ME/CFS symptoms during 12 months after intervention start date. The Overall Response is not predefined to a specific time interval during the 12 months of follow-up, but the response must be recorded as moderate or major on the patient self-report form. Overall Response is defined as mean Fatigue score = 4.5 for a minimum of 6 consecutive weeks for moderate response, and including a mean Fatigue score = 5.0 for a minimum of 6 consecutive weeks for major response. The duration and sum of the various response periods during the follow-up period will be recorded. ;Timepoint(s) of evaluation of this end point: Evaluation of changes in Fatigue scores from baseline at 0-3, 3-6, 6-9 and 9-12 months. Evaluation of Overall Response at 12 months for the whole follow-up period.	—

Measure

Time frame

Main Objective: The objective of this trial is to evaluate the efficacy, toxicity and feasibility of six infusions cyclophosphamide given four weeks apart, for patients with chronic fatigue syndrome (ME/CFS).;Secondary Objective: see secondary endpoints;Primary end point(s): The primary endpoint is recorded from the patient self-report form completed every two weeks during a follow-up period of 12 months after the first treatment. The variable Fatigue score is calculated every two weeks as the mean (scale 0-6) of the four symptoms: Fatigue, Post-exertional malaise, Need for rest and Daily function. The primary endpoint will be change in self-reported Fatigue score from baseline to mean scores during specific time intervals in the follow-up period (0-3, 3-6, 6-9 and 9-12 months), expressing the effect on the ME/CFS symptoms. The Overall Response records the effect on the ME/CFS symptoms during 12 months after intervention start date. The Overall Response is not predefined to a specific time interval during the 12 months of follow-up, but the response must be recorded as moderate or major on the patient self-report form. Overall Response is defined as mean Fatigue score = 4.5 for a minimum of 6 consecutive weeks for moderate response, and including a mean Fatigue score = 5.0 for a minimum of 6 consecutive weeks for major response. The duration and sum of the various response periods during the follow-up period will be recorded. ;Timepoint(s) of evaluation of this end point: Evaluation of changes in Fatigue scores from baseline at 0-3, 3-6, 6-9 and 9-12 months. Evaluation of Overall Response at 12 months for the whole follow-up period.

—

Secondary

Measure	Time frame
Secondary end point(s): -SF-36 scores (”Physical health summary score”, ”Mental health summary score” and scores for eight SF-36 subdimensions) are analysed at baseline and at 3, 6, 9 and 12 months. Changes will be analysed for the SF-36 ”Physical health summary score” (norm based), the SF-36-subdimension ”Physical Function” and changes in mean scores for the five SF-36 subdimensions ”Physical Function”, ”Bodily Pain”, ”Vitality”, ”Social Function” and ”General health”, from baseline to the predefined time points 3, 6, 9 and 12 months. -Changes in physical activity measured by a Sensewear armband for seven consecutive days, before intervention and again between 7 and 9 months after intervention start date, possibly also after 11-12 months. Changes will be recorded for mean number of steps per 24 hours, max. number of steps per 24 hours, mean duration of moderate activity = 3,5 METs per 24 hours, max. duration of moderate activity = 3,5 METs per 24 hours. -For the patients capable of completing a stress test, ergospirometry will be performed on two consecutive days, before intervention and repeated during the time interval 7-9 months after intervention start date, possibly also after 11-12 months. We will use a programmed ramp protocol with increasing work rate of 10 Watts/min, 15 Watts/min, 20 Watts/min, 25 Watts/min or 30 Watts/min, according to clinical assessment, gender and symptom severity. Oxygen uptake and exercise capacity (Watts) on day 2, at maximum work rate and anaerobic threshold are compared to the equivalent oxygen uptake and exercise capacity after 7-9 months, possibly also after 11-12 months. Changes from baseline (before intervention) to repeated test after 7-9 months (possibly also 11-12 months) are registered. -Changes in physical activity measured by a Sensewear armband for seven consecutive days, before intervention and again between 7 and 9 months after intervention start date, possibly also after 11-12 months. Changes will be reco	—

Measure

Time frame

Secondary end point(s): -SF-36 scores (”Physical health summary score”, ”Mental health summary score” and scores for eight SF-36 subdimensions) are analysed at baseline and at 3, 6, 9 and 12 months. Changes will be analysed for the SF-36 ”Physical health summary score” (norm based), the SF-36-subdimension ”Physical Function” and changes in mean scores for the five SF-36 subdimensions ”Physical Function”, ”Bodily Pain”, ”Vitality”, ”Social Function” and ”General health”, from baseline to the predefined time points 3, 6, 9 and 12 months. -Changes in physical activity measured by a Sensewear armband for seven consecutive days, before intervention and again between 7 and 9 months after intervention start date, possibly also after 11-12 months. Changes will be recorded for mean number of steps per 24 hours, max. number of steps per 24 hours, mean duration of moderate activity = 3,5 METs per 24 hours, max. duration of moderate activity = 3,5 METs per 24 hours. -For the patients capable of completing a stress test, ergospirometry will be performed on two consecutive days, before intervention and repeated during the time interval 7-9 months after intervention start date, possibly also after 11-12 months. We will use a programmed ramp protocol with increasing work rate of 10 Watts/min, 15 Watts/min, 20 Watts/min, 25 Watts/min or 30 Watts/min, according to clinical assessment, gender and symptom severity. Oxygen uptake and exercise capacity (Watts) on day 2, at maximum work rate and anaerobic threshold are compared to the equivalent oxygen uptake and exercise capacity after 7-9 months, possibly also after 11-12 months. Changes from baseline (before intervention) to repeated test after 7-9 months (possibly also 11-12 months) are registered. -Changes in physical activity measured by a Sensewear armband for seven consecutive days, before intervention and again between 7 and 9 months after intervention start date, possibly also after 11-12 months. Changes will be reco

—

Countries

Norway

Contacts

Public ContactØystein Fluge

Haukeland University Hospital

oystein.fluge@gmail.com+475597358700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026