Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo
Introduction: Methylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment. Objective: To explore the efficacy of methylphenidate in the relief of fatigue in patients with advanced cancer. Materials and methods: A...
| Autores: | , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | Universidad de Navarra |
| Repositorio: | Dadun. Depósito Académico Digital de la Universidad de Navarra |
| Idioma: | inglés |
| OAI Identifier: | oai:dadun.unav.edu:10171/120588 |
| Acceso en línea: | https://hdl.handle.net/10171/120588 |
| Access Level: | acceso abierto |
| Palabra clave: | Cancer Fatigue Pharmacology Supportive care |
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Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placeboCenteno, C. (Carlos)|||/items/51b2dfa8-5e18-4188-a2f8-410672dce680Rojí-Buqueras, R. (Rocío)|||/items/17f50445-2d2d-44c5-984e-8fc370afb6edPortela, M.A. (María Angustias)|||/items/26578562-34f0-4e7c-9d8d-39a88f7e68a6Santiago, A. (Ana) de|||/items/673224a1-8c95-4cb2-92e8-75afff4c3fe4Cuervo M. A. (Miguel Angel)|||/items/aabc0f41-c428-49ae-8a8f-f169d728b7f2Ramos, D. (Daniel)|||/items/fd8ea077-7c02-4563-8e55-8ccd19a9b963Gándara, A. (Álvaro)|||/items/f1fa23dd-1efa-4339-a5e4-b1e360025eebSalgado, E. (Esteban)|||/items/ae693898-1104-48d9-b217-f4097cfe2d6dGagnon, B. (Bruno)|||/items/967b2061-11c4-4937-a533-b63e8b9bc352Sanz, A. (Álvaro)|||/items/4b6cd2be-6620-431f-a12a-e2c1d5e858fcCancerFatiguePharmacologySupportive careIntroduction: Methylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment. Objective: To explore the efficacy of methylphenidate in the relief of fatigue in patients with advanced cancer. Materials and methods: A randomised double-blind placebo-controlled multicentre clinical trial, stratified according to the intensity of fatigue. The treatment was considered effective if the improvement in mean fatigue intensity between baseline values and day 6 was significantly higher in the methylphenidate group than in the placebo group. The responses were measured using the Edmonton Symptoms Assessment System (ESAS) and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scales. Results: 35 patients received placebo and 42 patients received methylphenidate. The populations of both groups were homogeneous. Patients receiving methylphenidate did not exhibit statistically significant improvement of fatigue in comparison to patients receiving placebo (p=0.52). The mean improvement of fatigue (ESAS) on day 6 was -1.9 (±2.5) in the placebo group, and -2.3 (±2.6) in the methylphenidate group (p=0.52). The results obtained with the FACT-F were congruent with those obtained by the ESAS. The responses in patients with severe fatigue were -2.4 (±2.9) in the placebo group and -3.4 (±2.5) in the methylphenidate group; the difference was not statistically significant (p=0.3). Conclusion: Methylphenidate was not more efficient than placebo to treat cancer-related fatigue. Fatigue improved significantly after 3 days of treatment and was stabilised on day 6, both with placebo and methylphenidate. The side effects of methylphenidate were mild and infrequent. Trial registration number: EudraCT Registry (2008-002171-27).BMJ Publishing GroupDadun. Depósito Académico Digital Universidad de Navarra20222022-01-0120222022-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/120588reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/1205882026-06-21T12:47:57Z |
| dc.title.none.fl_str_mv |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo |
| title |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo |
| spellingShingle |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo Centeno, C. (Carlos)|||/items/51b2dfa8-5e18-4188-a2f8-410672dce680 Cancer Fatigue Pharmacology Supportive care |
| title_short |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo |
| title_full |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo |
| title_fullStr |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo |
| title_full_unstemmed |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo |
| title_sort |
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo |
| dc.creator.none.fl_str_mv |
Centeno, C. (Carlos)|||/items/51b2dfa8-5e18-4188-a2f8-410672dce680 Rojí-Buqueras, R. (Rocío)|||/items/17f50445-2d2d-44c5-984e-8fc370afb6ed Portela, M.A. (María Angustias)|||/items/26578562-34f0-4e7c-9d8d-39a88f7e68a6 Santiago, A. (Ana) de|||/items/673224a1-8c95-4cb2-92e8-75afff4c3fe4 Cuervo M. A. (Miguel Angel)|||/items/aabc0f41-c428-49ae-8a8f-f169d728b7f2 Ramos, D. (Daniel)|||/items/fd8ea077-7c02-4563-8e55-8ccd19a9b963 Gándara, A. (Álvaro)|||/items/f1fa23dd-1efa-4339-a5e4-b1e360025eeb Salgado, E. (Esteban)|||/items/ae693898-1104-48d9-b217-f4097cfe2d6d Gagnon, B. (Bruno)|||/items/967b2061-11c4-4937-a533-b63e8b9bc352 Sanz, A. (Álvaro)|||/items/4b6cd2be-6620-431f-a12a-e2c1d5e858fc |
| author |
Centeno, C. (Carlos)|||/items/51b2dfa8-5e18-4188-a2f8-410672dce680 |
| author_facet |
Centeno, C. (Carlos)|||/items/51b2dfa8-5e18-4188-a2f8-410672dce680 Rojí-Buqueras, R. (Rocío)|||/items/17f50445-2d2d-44c5-984e-8fc370afb6ed Portela, M.A. (María Angustias)|||/items/26578562-34f0-4e7c-9d8d-39a88f7e68a6 Santiago, A. (Ana) de|||/items/673224a1-8c95-4cb2-92e8-75afff4c3fe4 Cuervo M. A. (Miguel Angel)|||/items/aabc0f41-c428-49ae-8a8f-f169d728b7f2 Ramos, D. (Daniel)|||/items/fd8ea077-7c02-4563-8e55-8ccd19a9b963 Gándara, A. (Álvaro)|||/items/f1fa23dd-1efa-4339-a5e4-b1e360025eeb Salgado, E. (Esteban)|||/items/ae693898-1104-48d9-b217-f4097cfe2d6d Gagnon, B. (Bruno)|||/items/967b2061-11c4-4937-a533-b63e8b9bc352 Sanz, A. (Álvaro)|||/items/4b6cd2be-6620-431f-a12a-e2c1d5e858fc |
| author_role |
author |
| author2 |
Rojí-Buqueras, R. (Rocío)|||/items/17f50445-2d2d-44c5-984e-8fc370afb6ed Portela, M.A. (María Angustias)|||/items/26578562-34f0-4e7c-9d8d-39a88f7e68a6 Santiago, A. (Ana) de|||/items/673224a1-8c95-4cb2-92e8-75afff4c3fe4 Cuervo M. A. (Miguel Angel)|||/items/aabc0f41-c428-49ae-8a8f-f169d728b7f2 Ramos, D. (Daniel)|||/items/fd8ea077-7c02-4563-8e55-8ccd19a9b963 Gándara, A. (Álvaro)|||/items/f1fa23dd-1efa-4339-a5e4-b1e360025eeb Salgado, E. (Esteban)|||/items/ae693898-1104-48d9-b217-f4097cfe2d6d Gagnon, B. (Bruno)|||/items/967b2061-11c4-4937-a533-b63e8b9bc352 Sanz, A. (Álvaro)|||/items/4b6cd2be-6620-431f-a12a-e2c1d5e858fc |
| author2_role |
author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Dadun. Depósito Académico Digital Universidad de Navarra |
| dc.subject.none.fl_str_mv |
Cancer Fatigue Pharmacology Supportive care |
| topic |
Cancer Fatigue Pharmacology Supportive care |
| description |
Introduction: Methylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment. Objective: To explore the efficacy of methylphenidate in the relief of fatigue in patients with advanced cancer. Materials and methods: A randomised double-blind placebo-controlled multicentre clinical trial, stratified according to the intensity of fatigue. The treatment was considered effective if the improvement in mean fatigue intensity between baseline values and day 6 was significantly higher in the methylphenidate group than in the placebo group. The responses were measured using the Edmonton Symptoms Assessment System (ESAS) and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scales. Results: 35 patients received placebo and 42 patients received methylphenidate. The populations of both groups were homogeneous. Patients receiving methylphenidate did not exhibit statistically significant improvement of fatigue in comparison to patients receiving placebo (p=0.52). The mean improvement of fatigue (ESAS) on day 6 was -1.9 (±2.5) in the placebo group, and -2.3 (±2.6) in the methylphenidate group (p=0.52). The results obtained with the FACT-F were congruent with those obtained by the ESAS. The responses in patients with severe fatigue were -2.4 (±2.9) in the placebo group and -3.4 (±2.5) in the methylphenidate group; the difference was not statistically significant (p=0.3). Conclusion: Methylphenidate was not more efficient than placebo to treat cancer-related fatigue. Fatigue improved significantly after 3 days of treatment and was stabilised on day 6, both with placebo and methylphenidate. The side effects of methylphenidate were mild and infrequent. Trial registration number: EudraCT Registry (2008-002171-27). |
| publishDate |
2022 |
| dc.date.none.fl_str_mv |
2022 2022-01-01 2022 2022-01-01 |
| dc.type.none.fl_str_mv |
journal article http://purl.org/coar/resource_type/c_6501 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/10171/120588 |
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https://hdl.handle.net/10171/120588 |
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Inglés eng |
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Inglés |
| language |
eng |
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open access http://purl.org/coar/access_right/c_abf2 |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 |
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openAccess |
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application/pdf |
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BMJ Publishing Group |
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BMJ Publishing Group |
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reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra |
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Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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15.81155 |