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CycloME
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'''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.<ref name="Rekeland2020"/><ref name="PhaseII"/> The Kavli Trust, a humanitarian foundation,<ref>{{Cite web | url = https://kavlifondet.no/en/ | title = Kavlifondet | website = Kavli Trust|language=en-GB|access-date=2022-01-26}}</ref> is contributed to the trial by funding 50% of a nursing post for 12 months.<ref name="mystery">{{Cite web | url = https://kavlifondet.no/en/2015/04/tackling-a-medical-mystery/ | title = Tackling a medical mystery | date = 2015-04-10 | website = Kavli Trust|language=en-GB|access-date=2022-01-26}}</ref> ==Cyclophosphamide== [[Cyclophosphamide]], a chemotherapy and immunosuppressant drug, has been investigated as a treatment in ME/CFS.<ref name="PhaseII">{{Cite web | title = Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS). Part A: an Open Label Phase-II Study With Six Intravenous Cyclophosphamide Infusions Four Weeks Apart, and Follow-up for 12 Months | date = 2021-05-10 | url = https://clinicaltrials.gov/ct2/show/NCT02444091 | last = Haukeland University Hospital|others=The Kavli Foundation, Oslo University Hospital}}</ref><ref name="Rekeland2020" /> 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.<ref name="mystery" /> ==CycloME part A== The first cyclophosphamide trial was a single centre, unblinded study with 40 patients with mild/moderate to [[Severe and very severe ME|severe ME]] but not very severe ME.<ref name="PhaseII" /> Some of the participants were previously treated with [[Rituximab]].<ref name="PhaseII"/> The Department of Oncology at Haukeland University Hospital was responsible for assessing which patients to include the trial, as well as administering the treatments. The Norwegian Radium Hospital, Oslo, took part in the trial as a treatment centre, administering treatments to a small group of patients from the Oslo area.<ref name="PhaseII" /> The [[Canadian Consensus Criteria]] was used in selecting participants.<ref name="PhaseII" /> All participants received six intravenous treatments of [[cyclophosphamide]], each treatment four weeks apart. The participants was followed-up for one year. Each was given complete physical examinations and testing before and after treatment, and submitted regular reports on any changes in symptoms and physical function.<ref name="Rekeland2020" /> The physical function testing included a measurement of activity via a Sensewear armband (a wearable device that measures physical activity and total energy expenditure expressed as Kcal), two-day Cardiopulmonary exercise tests for those who are able, and self-reporting fatigue scores. Adverse effects were tested for with physical examinations and laboratory tests.<ref name="Rekeland2020" /> Side effects were expected to be minimal, because similar dosages have already been used in breast cancer and lymphoma trials, although some serious adverse responses did occur.<ref name="PhaseII" /><ref name="Rekeland2020" /> Study results were published in 2020.<ref name="Rekeland2020" /> Data analysis included comparing the group who received [[rituximab]] prior to those who did not.<ref name="Rekeland2020" /> ==CycloME part B== The Haukeland University Hospital ME/CFS research group found positive interim results from CycloME part A in over 40% of the patients, so began part B, although the trial was not extended to include patients with very severe ME. In part B, both treatment and follow-up were completed in collaboration with the patient’s local primary health service.<ref name="Rekeland2020" /> == Study outcome measures == Primary Outcome Measures: * Self reported fatigue score, and * overall response as the effect of treatment on ME/CFS symptoms, both measured within a 12 months follow-up period.<ref name="PhaseII" /><ref name="Rekeland2020" /> Secondary Outcome Measures: *[[Short-Form 36]] ([[SF-36]]), recorded at baseline, and at 3, 6, 9 and 12 months follow-up, *Physical activity via a Sensewear armband, recorded at baseline, at 7-9 months, and at 11-12 months, *[[Cardiopulmonary exercise test]]s for two following days, performed at baseline, and repeated at 7-9 months, and 11-12 months, *Self-recorded Function level, recorded at baseline, and at 3, 6, 9 and 12 months follow-up, *[[Fatigue Severity Scale]] (FSS), completed at baseline, 3, 6, 9 and 12 months, *Longest duration of continuous response duration, measured by a self-reported fatigue score ≥ 4,5 (for at least 6 consecutive weeks) within 12 months follow-up, *Sustained clinical response at 12 months, defined as a fatigue score of at least 4.5 at 12 months follow-up, and *Safety and tolerability, including [[adverse event]]s, measured by patient history, physical exam, and lab tests, performed every four weeks the first six months, thereafter at 6, 9 and 12 months follow-up. Adverse events were likely to include hair loss, vomiting, [[diarrhea]], jaundice, leukopenia, [[anemia]], thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis, disturbed ovarian function. Information collection on possible toxicity continued after the formal 12 months study period.<ref name="PhaseII" /><ref name="Rekeland2020" /> The final follow up continued 3-4 years.<ref name="Rekeland2020" /> ==Side effects == Most patients reported one of two side effects, the most common being [[nausea]], [[infection]]s and [[constipation]].<ref name="Rekeland2020" /> ==Results == Rekeland et al. (2020) found that responders roughly doubled the number of steps they could take, and were more likely to have [[mild myalgic encephalomyelitis or chronic fatigue syndrome|mild]]/moderate or [[moderate myalgic encephalomyelitis or chronic fatigue syndrome|moderate ME/CFS]]. Over half of patients responded, with HLA-B allelles being linked to a much higher chance of response.<ref name="Rekeland2020"/> Further trials of [[cyclophosphamide]] are planned. ==Notable studies== * 2020, Intravenous Cyclophosphamide in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. An Open-Label Phase II Study<ref name="Rekeland2020">{{Cite journal | last = Rekeland | first = Ingrid G. | authorlink = Ingrid Rekeland | last2 = Fosså | first2 = Alexander | authorlink2 = | last3 = Lande | first3 = Asgeir | author-link3 = | last4 = Ktoridou-Valen | first4 = Irini | author-link4 = | last5 = Sørland | first5 = Kari | author-link5 = Kari Sørland | last6 = Holsen | first6 = Mari | author-link6 = | last7 = Tronstad | first7 = Karl J. | author-link8 = Karl Tronstad | last8 = Risa | first8 = Kristin | author-link8 = | last9 = Alme | first9 = Kine | author-link9 = | date = 2020 | title=Intravenous Cyclophosphamide in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. An Open-Label Phase II Study | url = https://www.frontiersin.org/articles/10.3389/fmed.2020.00162/full|journal=Frontiers in Medicine|language=English|volume=7|issue= | pages = 162|pmc=PMC7201056|pmid=32411717|doi=10.3389/fmed.2020.00162|issn=2296-858X|quote=|via= | last10 = Viken | first10 = Marte K. | author-link10 = | last11 = Lie | first11 = Benedicte K. | author-link11 = | last12 = Dahl | first12 = Olav | author-link12 = | last13 = Mella | first13 = Olav | author-link13 = Olav Mella | first14 = Øystein | last14 = Fluge | author-link14 = Øystein Fluge}}</ref> - [https://www.frontiersin.org/articles/10.3389/fmed.2020.00162/full? (Full text)] * 2021, Reduced Endothelial Function in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome<ref name="Sorland2021">{{Cite journal | title = Reduced Endothelial Function in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome–Results From Open-Label Cyclophosphamide Intervention Study | date = 2021 | url=https://www.frontiersin.org/article/10.3389/fmed.2021.642710|journal=Frontiers in Medicine|volume=8 | last = Sørland | first = Kari | authorlink = Kari Sørland | last2 = Sandvik | first2 = Miriam Kristine | last3 = Rekeland | first3 = Ingrid Gurvin | author-link3 = Ingrid Rekeland | last4 = Ribu | first4 = Lis | last5 = Småstuen | first5 = Milada Cvancarova | last6 = Mella | first6 = Olav | author-link6 = Olav Mella | last7 = Fluge | first7 = Øystein | author-link8 = Øystein Fluge|doi=10.3389/fmed.2021.642710|pmc=PMC8019750|pmid=33829023|issn=2296-858X}}</ref> - [https://doi.org/10.3389/fmed.2021.642710 (Full text)] ==Learn more== *20 Oct 2016, [https://www.youtube.com/watch?v=cPlhjgXRKlE The] [[RituxME]] and CycloME studies – Ongoing Clinical Research in the ME/CFS Research Group *[https://helse-bergen.no/seksjon-engelsk/seksjon/Cancer%20Treatment%20and%20Medical%20Physics/Sider/CycloME.aspx CycloME website] *[https://clinicaltrials.gov/ct2/show/NCT02444091 ClinicalTrial.gov page for CycloME study] ==See also== *[[2004 Bergen, Norway outbreak]] *[[RituxME]] *[[Rituximab]] ==References== {{Reflist}} [[Category:Notable studies]]
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