Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study

Официальное название

Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study

Обзор

The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.

Подробное описание

Many experts advocate the use of Photobiomodulation (PBM) therapy in patients with cancer and demand studies of higher methodological quality such as randomized controlled clinical trials. However, there is no consensus on the most effective dosimetry that allows us to establish an effective and safe approach to treat radiotherapy-induced xerostomia in head and neck cancer survivors. Finally, recent reviews highlight the importance of determining whether or not the effects of Photobiomodulation therapy are maintained after a follow-up period.

Вмешательства

• Устройство Energy density photobiomodulation (7.5)
  A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided.
• Устройство Energy density photobiomodulation (3)
  A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided.
• Устройство Sham placebo
  In addition, a mobile health application (LAXER) will be provided.

Первичные конечные точки

• General and specific quality of life. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Oral Health. Severity of xerostomia. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Oral Health. Dysphagia. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Oral Health. Perceived xerostomia. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Oral Health. Degree of mouth opening. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Oral Health. Clinical physical findings (dryness in the mouth). [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Oral Health. Regional oral dryness. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Salivary secretion. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Salivary gland ultrasound assessment. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]

Вторичные конечные точки (7)

• Pressure pain threshold. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Functional Performance. Functional capacity. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Functional Performance. Mobility/fall risk. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Functional Performance. Perceived fitness status. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Functional Performance. Physical activity level. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Mood. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]
• Sleep quality. [Срок оценки: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).]

Критерии участия

Patients will be included in the study if they meet the following inclusion criteria:

• men or women aged 18 years or older and were diagnosed with HNC.
• chronic xerostomia.
• received RT in the parotid, submandibular and/or sublingual salivary glands.
• grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).
• medical treatment completed and in complete remission.
• received medical clearance for participation in this study.
• at least one month passed since the end of RT to avoid the possible presence of oral mucositis and/or radiodermatitis, which limits adherence to treatment and maximum 36 months.
• no history of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion.
• and able to access mobile applications or living with someone who has this ability.

The exclusion criteria will be as follows:

• patients with metastases.
• a score <60 on the Karnofsky Performance Status Scale.
• contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy).
• other comorbidities such as diabetes and polypharmacy.
• and retraction of the declaration of consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Faculty of Health Sciences — Granada

Публикации

• Lozano-Lozano M, Lopez-Garzon M, Cuadrado-Guerrero P, Postigo-Martin P, Fernandez-Lao C, Tovar-Martin I, Galiano-Castillo N. Reliability of the electronic patient reported outcome measures for assessing xerostomia, dysphagia and quality of life in Spanish patients with head and neck cancer: a randomised crossover design. Health Qual Life Outcomes. 2025 Mar 3;23(1):19. doi: 10.1186/s12955-025-02347 PMID 40033397
• Lopez-Garzon M, Lopez-Fernandez MD, Ruiz-Martinez AM, Galvan-Banqueri P, Lozano-Lozano M, Tovar-Martin I, Postigo-Martin P, Ariza-Vega P, Artacho-Cordon F, Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-Gualda MA, Arroyo-Morales M, Ruiz-Villaverde R, Galiano-Castillo N. Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering PMID 38267245

Идентификаторы

NCT: NCT05106608 · PBM_CANCER21 · PI-0187-2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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