ArticleTrials2019
Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: a study protocol for a cost-effectiveness randomized clinical trial.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Effects of low-level light therapy on xerostomia related to hyposalivation: a systematic review and meta-analysis of clinical trials.Lasers in medical science · 2022Pooled it
- Combined extraoral and intraoral photobiomodulation for the prevention and management of oral mucositis and Xerostomia caused by the treatment of head and neck cancers.Lasers in medical science · 2025Trial
- Cost-effectiveness randomized clinical trial on the effect of photobiomodulation therapy for prevention of radiotherapy-induced severe oral mucositis in a Brazilian cancer hospital setting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Trial
- Assessing the Cost-Effectiveness of Photobiomodulation for Oral Mucositis Prevention and Treatment: A Systematic Review.Biomedicines · 2024Review
- Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT.Health technology assessment (Winchester, England) · 2022Article
- Impact of photobiomodulation for oral mucositis on body weight and BMI of patients with head and neck cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Photobiomodulation Therapy in the Treatment of Oral Mucositis-A Case Report.Medicina (Kaunas, Lithuania) · 2022Article
- Does photobiomodulation therapy improve the postoperative outcomes of tonsillectomy? A systematic review and meta-analysis.Journal of lasers in medical sciences · 2022Review
- Photobiomodulation reduces the impact of radiotherapy on oral health-related quality of life due to mucositis-related symptoms in head and neck cancer patients.Lasers in medical science · 2021Article
- Prophylactic photobiomodulation therapy using 660 nm diode laser for oral mucositis in paediatric patients under chemotherapy: 5-year experience from a Brazilian referral service.Lasers in medical science · 2020Article
- Photobiomodulation Therapy in Oral Mucositis and Potentially Malignant Oral Lesions: A Therapy Towards the Future.Cancers · 2020Review
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundOral mucositis (OM) is the most frequent and debilitating acute side effect associated with head and neck cancer (HNC) treatment. When present, severe OM negatively impacts the quality of life of patients undergoing HNC treatment. Photobiomodulation is a well-consolidated and effective therapy for the treatment and prevention of severe OM, and is associated with a cost reduction of the cancer treatment. Although an increase in the quality of life and a reduction in the severity of OM are well described, there is no study on cost-effectiveness for this approach considering the quality of life as a primary outcome. In addition, little is known about the photobiomodulation effects on salivary inflammatory mediators. Thus, this study aimed to assess the cost-effectiveness of the photobiomodulation therapy for the prevention and control of severe OM and its influence on the salivary inflammatory mediators. METHODS/
designThis randomized, double-blind clinical trial will include 50 HNC patients undergoing radiotherapy or chemoradiotherapy. The participants will be randomized into two groups: intervention group (photobiomodulation) and control group (preventive oral care protocol). OM (clinical assessment), saliva (assessment of collected samples) and quality of life (Oral Health Impact Profile-14 and Patient-Reported Oral Mucositis Symptoms questionnaires) will be assessed at the 1st, 7th, 14th, 21st and 30th radiotherapy sessions. Oxidative stress and inflammatory cytokine levels will be measured in the saliva samples of all participants. The costs are identified, measured and evaluated considering the radiotherapy time interval. The incremental cost-effectiveness ratio will be estimated. The study will be conducted according to the Brazilian public health system perspective. DISCUSSION: Photobiomodulation is an effective therapy that reduces the cost associated with OM treatment. However, little is known about its cost-effectiveness, mainly when quality of life is the effectiveness measure. Additionally, this therapy is not supported by the Brazilian public health system. Therefore, this study widens the knowledge about the safety of and strengthens evidence for the use of photobiomodulation therapy, providing information for public policy-makers and also for dental care professionals. This study is strongly encouraged due to its clinical relevance and the possibility of incorporating new technology into public health systems.
trial registrationBrazilian Registry of Clinical Trials-ReBEC, RBR-5h4y4n . Registered on 13 June 2017.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.