5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment
Abstract Background Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contri...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-04-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-08078-w |
| _version_ | 1797219605201027072 |
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| author | Mojtaba Miladinia Mina Jahangiri Sharon Jackson White Hossein Karimpourian Alessandro Inno Sally Wai-Chi Chan Reza Ganji Mahmood Maniati Kourosh Zarea Marziyeh Ghalamkari Ali Farahat Cecilia Fagerström |
| author_facet | Mojtaba Miladinia Mina Jahangiri Sharon Jackson White Hossein Karimpourian Alessandro Inno Sally Wai-Chi Chan Reza Ganji Mahmood Maniati Kourosh Zarea Marziyeh Ghalamkari Ali Farahat Cecilia Fagerström |
| author_sort | Mojtaba Miladinia |
| collection | DOAJ |
| description | Abstract Background Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer. Methods The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0–10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups. Discussion The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines. Trial registration IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023. |
| first_indexed | 2024-04-24T12:36:18Z |
| format | Article |
| id | doaj.art-85e763c15d5b4c57a22ff670daf63afd |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-24T12:36:18Z |
| publishDate | 2024-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-85e763c15d5b4c57a22ff670daf63afd2024-04-07T11:29:28ZengBMCTrials1745-62152024-04-0125111210.1186/s13063-024-08078-w5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatmentMojtaba Miladinia0Mina Jahangiri1Sharon Jackson White2Hossein Karimpourian3Alessandro Inno4Sally Wai-Chi Chan5Reza Ganji6Mahmood Maniati7Kourosh Zarea8Marziyeh Ghalamkari9Ali Farahat10Cecilia Fagerström11Nursing Care Research Center in Chronic Diseases, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical SciencesDepartment of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares UniversitySchool of Nursing, Clayton State UniversityDepartment of Medical Oncology, School of Medicine, Ahvaz Jundishapur University of Medical SciencesMedical Oncology Unit, IRCCS Ospedale Sacro Cuore Don CalabriaTung Wah CollegeDepartment of Clinical Pharmacy, School of Pharmacy, Ahvaz Jundishapur University of Medical SciencesSchool of Medicine, Ahvaz Jundishapur University of Medical SciencesNursing Care Research Center in Chronic Diseases, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical SciencesDepartment of Internal Medicine, School of Medicine, Iran University of Medical SciencesDepartment of Hematology and Oncology, School of Medicine, Shahid Sadoughi University of Medical SciencesDepartment of Health and Caring Sciences, Faculty of Health and Life Sciences, Linnaeus UniversityAbstract Background Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer. Methods The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0–10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups. Discussion The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines. Trial registration IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023.https://doi.org/10.1186/s13063-024-08078-wFatiguePharmacological treatmentProtocolRandomized controlled trialStudy design |
| spellingShingle | Mojtaba Miladinia Mina Jahangiri Sharon Jackson White Hossein Karimpourian Alessandro Inno Sally Wai-Chi Chan Reza Ganji Mahmood Maniati Kourosh Zarea Marziyeh Ghalamkari Ali Farahat Cecilia Fagerström 5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment Trials Fatigue Pharmacological treatment Protocol Randomized controlled trial Study design |
| title | 5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment |
| title_full | 5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment |
| title_fullStr | 5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment |
| title_full_unstemmed | 5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment |
| title_short | 5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment |
| title_sort | 5 epifat trial protocol a multi center randomized placebo controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate bupropion ginseng and amantadine in advanced cancer patients on active treatment |
| topic | Fatigue Pharmacological treatment Protocol Randomized controlled trial Study design |
| url | https://doi.org/10.1186/s13063-024-08078-w |
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