Evaluation of the Efficacy of Photobiomodulation Protocols in Preventing Hyposalivation in Patients Undergoing Head and Neck Radiotherapy: A Randomized Clinical Trial
Head and neck cancer; radiotherapy; hyposalivation; xerostomia; photobiomodulation; saliva; oxidative stress
Head and neck cancer (HNC) is the seventh most prevalent type of cancer worldwide, with incidence and mortality rates that vary considerably across different geographic regions. Radiotherapy is one of the most commonly used treatment modalities, aiming to destroy or inhibit the proliferation of tumor cells, thereby achieving tumor control. However, radiation exposure may also damage adjacent healthy tissues, particularly the salivary glands. Hyposalivation and xerostomia are common adverse effects that have a substantial negative impact on patients' quality of life, as they directly impair essential oral functions, including chewing, swallowing, speaking, and taste perception. Although several therapeutic approaches have been proposed for the management of radiation-induced salivary gland dysfunction, photobiomodulation has emerged as a promising strategy for both prevention and treatment due to its biostimulatory effects, which enhance cellular metabolism and may contribute to the preservation or recovery of salivary gland function. Therefore, studies investigating the effectiveness of photobiomodulation are essential to provide evidence-based preventive and therapeutic options for patients undergoing radiotherapy for head and neck cancer.The present study aims to evaluate the efficacy of different photobiomodulation protocols in preventing hyposalivation and to investigate their effects on salivary oxidative stress and antioxidant biomarkers in patients undergoing radiotherapy for head and neck cancer. Patients diagnosed with HNC and scheduled to receive primary radiotherapy will be randomly allocated to one of four study groups: infrared photobiomodulation, red photobiomodulation, combined (red and infrared) photobiomodulation, or a placebo group. All participants will undergo unstimulated sialometry, clinical assessment for hyposalivation, and evaluation of xerostomia using validated questionnaires. In addition, saliva samples collected throughout the study will be analyzed for oxidative stress and antioxidant biomarkers. All participants will receive detailed information regarding the study objectives and procedures and, upon agreeing to participate, will provide written informed consent. The study has been approved by the Research Ethics Committees of the Liga Norte Riograndense Contra o Câncer and the Federal University of Rio Grande do Norte (UFRN).