Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study.

Autor:	Lopez-Garzon M; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Sport and Health Research Center (IMUDs), Parque Tecnológico de la Salud, Granada, Spain., López-Fernández MD; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain e.mlopezf@go.ugr.es.; Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain., Ruíz-Martínez AM; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Department of Radiation Oncology, Hospital Universitario Virgen de las Nieves, Granada, Spain., Galván-Banqueri P; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Department of Radiation Oncology, Hospital Universitario Virgen de las Nieves, Granada, Spain., Lozano-Lozano M; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Sport and Health Research Center (IMUDs), Parque Tecnológico de la Salud, Granada, Spain., Tovar-Martín I; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Department of Radiation Oncology, Hospital Universitario Virgen de las Nieves, Granada, Spain., Postigo-Martin P; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Sport and Health Research Center (IMUDs), Parque Tecnológico de la Salud, Granada, Spain., Ariza-Vega P; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Physical Activity for HEaLth Promotion (PA-HELP), Department of Physical and Sport Education, Sports Sciences Faculty, University of Granada, Granada, Spain., Artacho-Cordón F; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Department of Radiology and Physical Medicine, Medicine Faculty, University of Granada, Granada, Spain.; CIBER de Epidemiología y Salud Pública, CIBERESP, Madrid, Spain., Fernández-Lao C; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Sport and Health Research Center (IMUDs), Parque Tecnológico de la Salud, Granada, Spain., Cantarero-Villanueva I; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Sport and Health Research Center (IMUDs), Parque Tecnológico de la Salud, Granada, Spain., Fernández-Gualda MÁ; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain., Arroyo-Morales M; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Sport and Health Research Center (IMUDs), Parque Tecnológico de la Salud, Granada, Spain., Ruíz-Villaverde R; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Department of Medical Surgical Dermatology and Venereology, Hospital Universitario Clínico San Cecilio, Granada, Spain., Galiano-Castillo N; Biomedical Group (BIO277), Department of Physical Therapy, Health Sciences Faculty, University of Granada, Granada, Spain.; Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain.; Sport and Health Research Center (IMUDs), Parque Tecnológico de la Salud, Granada, Spain.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jan 24; Vol. 14 (1), pp. e078068. Date of Electronic Publication: 2024 Jan 24.
DOI:	10.1136/bmjopen-2023-078068
Abstrakt:	Introduction: The role of photobiomodulation (PBM) therapy for oral tissue damage induced by cancer treatment is currently unclear, and there is low-quality to moderate-quality evidence supporting the use of this approach for treating xerostomia and/or hyposalivation. Consequently, patients with head and neck cancer increasingly turn to basic oral hygiene to alleviate salivary gland dysfunction, and their adherence can be improved by mobile health (mHealth) education. The primary objective of this study will be to analyse the effects of different doses of PBM therapy (7.5 J/cm 2 vs 3 J/cm 2 ) plus mHealth education on quality of life (QoL), oral health, salivary secretion and salivary gland ultrasound assessment at postintervention and at the 6-month follow-up in patients with head and neck cancer after radiotherapy compared with those in control group. Methods and Analysis: A prospective, three-arm, randomised, placebo-controlled, double-blinded study will be conducted among patients with head and neck cancer suffering from chronic xerostomia. A total of 20 patients per arm will be included and randomly assigned to receive 7.5 J/cm 2 of PBM, 3 J/cm 2 of PBM or placebo therapy. PBM therapy will be applied during 24 sessions at 22 points extra and intraorally two times per week for 3 months, combined with a mobile application (https://www.laxer.es). The assessments will be recorded at the beginning of the study, at postintervention and at the 6-month follow-up. The primary outcomes will be QoL, oral health, salivary secretion and salivary gland ultrasound. The pain pressure threshold, functional performance, mood and sleep quality will be secondary indicators. Ethics and Dissemination: This study received ethics approval from the Andalusian Biomedical Research Ethics Portal (2402-N-21 CEIM/CEI Provincial de Granada) according to the Declaration of Helsinki for Biomedical Research. The results of this study will be presented at national and international conferences and published in peer-reviewed journals. Trial Registration Number: ClinicalTrials.gov NCT05106608. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu