The effect on quality of life of vitamin d administration for advanced cancer treatment (vidafact study): Protocol of a randomised controlled trial
Data de publicació2015
MetadadesMostra el registre d'unitat complet
Introduction: Vitamin D is related to resistance to chronic diseases, physiological parameters and functional measures. All of these relationships underscore the potential benefits of cholecalciferol or D3 (nutritional vitamin D) in cancer. This is the first study designed to obtain conclusive evidence
on the effect of cholecalciferol in advanced patients with cancer. The main goal is to assess its effects on the patient’s perceived quality of life. Cholecalciferol’s impact on fatigue and physical performance, as well as its cost utility, will also be assessed. Methods and analysis: A randomised triple-blind phase II/III placebo-controlled multicentre trial has been designed. Patients satisfying the inclusion and exclusion criteria will be randomly assigned to receive cholecalciferol or placebo. Eligible patients will be adults with a locally advanced or metastatic or inoperable solid cancer in palliative care, who have given signed informed consent and have matched inclusion and exclusion criteria. The randomisation will be based on a computer-generated procedure and centralised by the pharmacy service of the coordinating centre. The assigned treatment will be administered by the hospital’s pharmacy to conceal group allocation for patients and healthcare providers. Cholecalciferol (4000 IU/day) or placebo, starting at day 15 and continuing up to day 42, will be added to palliative care treatment. Outpatient visits will be scheduled every 14 days. Ethics and dissemination: Ethical approval was received from the Medical Ethical Commitee of the HUAV (CEIC-1169). Participants and their families will receive the research findings which will also be disseminated on local and national media, presented at national and international meetings of the specialty, and published in peer-reviewed scientific journals. Trial registration number: EudraCT: 2013-003478-29
És part deBMJ Open, 2015, vol. 4, núm 12, p. 1-7
Els fitxers de llicència següents estan associats amb aquest element:
Aquest document està subjecte a una llicència Creative Commons.cc-by-nc (c) Martínez Alonso, Montserrat et al., 2015
Mostrant elements relacionats per títol, autor i matèria.
The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial Misericòrdia, Carles; Martínez Alonso, Montserrat; Pons Rodríguez, Anna; Pérez Lacasta, María José; Perestelo Pérez, Lilisbeth; Sala, Maria; Vidal, Carmen; Garcia, Montse; Toledo Chávarri, Ana; Codern, Núria; Feijoo Cid, Maria; Romero, Anabel; Pla, Roger; Soler González, Jorge; Castells, Xavier; Rué i Monné, Montserrat (BioMed Central, 2017)The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary ...
Grotsky, David A.; González-Suárez, Ignacio; Novell Álvarez, Anna; Neumann, Martin; Yaddanapudi, Sree C.; Croke, Monica; Martínez Alonso, Montserrat; Redwood, Abena B.; Ortega-Martinez, Sylvia; Feng, Zhihui; Lerma, Enrique; Ramon y Cajal, Teresa; Zhang, Junran; Matias-Guiu, Xavier; Dusso Rosso, Adriana; Gonzalo, Susana (The Rockefeller University Press, 2013)Loss of 53BP1 rescues BRCA1 deficiency and is associated with BRCA1-deficient and triple-negative breast cancers (TNBC) and with resistance to genotoxic drugs. The mechanisms responsible for decreased 53BP1 transcript ...
Vitamin D deficiency is associated with poorer satisfaction with diabetes-related treatment and quality of life in patients with type 2 diabetes: a cross-sectional study Alcubierre Calvo, Núria; Castelblanco Echavarría, Esmeralda; Martínez Alonso, Montserrat; Granado Casas, Minerva; Esquerda, Aureli; Traveset Maeso, Alicia; Martínez González, María Dolores; Franch-Nadal, Josep; Mauricio Puente, Dídac (BioMed Central, 2018-03-12)Background: In this cross-sectional study, we assessed the possible association of vitamin D deficiency with self-reported treatment satisfaction and health-related quality of life in patients with type 2 diabetes. Methods: ...