{"id":25820,"date":"2020-05-04T22:21:18","date_gmt":"2020-05-04T22:21:18","guid":{"rendered":"https:\/\/wames.org.uk\/cms-english\/?p=25820"},"modified":"2020-05-19T05:20:27","modified_gmt":"2020-05-19T05:20:27","slug":"intravenous-cyclophosphamide-in-me-cfs-an-open-label-phase-ii-study","status":"publish","type":"post","link":"https:\/\/wames.org.uk\/cms-english\/intravenous-cyclophosphamide-in-me-cfs-an-open-label-phase-ii-study\/","title":{"rendered":"Intravenous cyclophosphamide in ME\/CFS. An open-label phase II study"},"content":{"rendered":"

Intravenous Cyclophosphamide in Myalgic Encephalomyelitis\/Chronic Fatigue Syndrome. An Open-Label Phase II Study<\/a> by Ingrid G Rekeland, Alexander Foss\u00e5, Asgeir Lande, Irini Ktoridou-Valen, Kari S\u00f8rland, Mari Holsen, Karl J Tronstad, Kristin Risa, Kine Alme, Marte K Viken, Benedicte A Lie, Olav Dahl, Olav Mella and \u00d8ystein Fluge\u00a0in <\/u>Front. Med<\/em>., 29 April 2020 [doi.org\/10.3389\/fmed.2020.00162]<\/h3>\n

 <\/p>\n

Research abstract:<\/strong><\/h3>\n

Introduction:<\/strong><\/p>\n

Myalgic Encephalomyelitis\/Chronic Fatigue Syndrome (ME\/CFS) is a disease with high symptom burden, of unknown etiology, with no established treatment. We observed patients with long-standing ME\/CFS who got cancer, and who reported improvement of ME\/CFS symptoms after chemotherapy including cyclophosphamide, forming the basis for this prospective trial.<\/p>\n

Materials and methods:<\/strong><\/p>\n

\"\"This open-label phase II trial included 40 patients with ME\/CFS diagnosed by Canadian criteria. Treatment consisted of six intravenous infusions of cyclophosphamide, 600\u2013700 mg\/m2, given at four-week intervals with follow-up for 18 months, extended to 4 years. Response was defined by self-reported improvements in symptoms by Fatigue score, supported by Short Form 36<\/a> (SF-36) scores, physical activity measures and other instruments. Repeated measures of outcome variables were assessed by General linear models. Responses were correlated with specific Human Leukocyte Antigen<\/a> (HLA) alleles.<\/p>\n

Results:<\/strong><\/p>\n

The overall response rate by Fatigue score was 55.0% (22 of 40 patients). Fatigue score and other outcome variables showed significant improvements compared to baseline. The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders. Mean steps per 24 h increased from mean 3,199 at baseline to 4,347 at 18 months (all patients), and from 3,622 to 5,589 among responders. At extended follow-up to 4 years 68% (15 of 22 responders) were still in remission. Patients positive for HLA-DQB1*03:03 and\/or HLA-C*07:04 (n = 12) had significantly higher response rate compared to patients negative for these alleles (n = 28), 83 vs. 43%, respectively. Nausea and constipation were common grade 1\u20132 adverse events. There were one suspected unexpected serious adverse reaction (aggravated POTS) and 11 serious adverse events in eight patients.<\/p>\n

Conclusion:<\/strong><\/p>\n

Intravenous cyclophosphamide treatment was feasible for ME\/CFS patients and associated with an acceptable toxicity profile. More than half of the patients responded and with prolonged follow-up, a considerable proportion of patients reported ongoing remission. Without a placebo group, clinical response data must be interpreted with caution. We nevertheless believe a future randomized trial is warranted.<\/p>\n

Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02444091<\/a>.<\/em><\/p>\n

MEPedia: <\/span><\/strong>\u00a0Cyclo ME study<\/a> \u00a0 Cyclo ME study part A<\/a><\/p>\n

Promising results from trial of cancer drug in ME\/CFS<\/a> –\u00a0but results should be interpreted with caution, according to researchers from Haukeland University Hospital.<\/p>\n","protected":false},"excerpt":{"rendered":"

Intravenous Cyclophosphamide in Myalgic Encephalomyelitis\/Chronic Fatigue Syndrome. An Open-Label Phase II Study by Ingrid G Rekeland, Alexander Foss\u00e5, Asgeir Lande, Irini Ktoridou-Valen, Kari S\u00f8rland, Mari Holsen, Karl J Tronstad, Kristin Risa, Kine Alme, Marte K Viken, Benedicte A Lie, Olav … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[1],"tags":[5876,5877,5750,826,5884,5883,1618,3507,5878,3506,5880,5882,5881,5879,5749,5875,5874,1102],"class_list":["post-25820","post","type-post","status-publish","format-standard","hentry","category-news","tag-alexander-fossa","tag-asgeir-lande","tag-benedicte-a-lie","tag-cancer","tag-chemotherapy","tag-cyclome-study","tag-cyclophosphamide","tag-ingrid-g-rekeland","tag-irini-ktoridou-valen","tag-kari-sorland","tag-karl-j-tronstad","tag-kine-alme","tag-kristin-risa","tag-mari-holsen","tag-marte-k-viken","tag-olav-dahl","tag-oystein-fluge","tag-prof-olav-mella"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p5qkYK-6Is","_links":{"self":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/25820","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/comments?post=25820"}],"version-history":[{"count":4,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/25820\/revisions"}],"predecessor-version":[{"id":26184,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/25820\/revisions\/26184"}],"wp:attachment":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/media?parent=25820"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/categories?post=25820"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/tags?post=25820"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}