Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy

Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy

Patients with head and neck cancer post-radiotherapy may improve their perceived and amount of saliva after a 3-month Photobiomodulation (PBM) therapy focuses on three main salivary glands (parotid, submandibular and sublingual glands).

The use of PBM therapy in survivors with head and neck cancer may be an effective treatment to improve xerostomia and hyposalivation as side effects of radiotherapy. Although there is some scientific evidence on its benefits during or after radiotherapy, it is not sufficient to establish it as an effective treatment. For these reasons, studies of higher methodological quality such as randomized controlled trials, are needed. This study aims to demonstrate the benefits of PBM therapy on xerostomia and hyposalivation in survivors with head and neck cancer undergone radiotherapy, and whether the effects are maintained after a follow-up period.

Inclusion Criteria:

• Patients diagnosed with head and neck cancer
• Persistent xerostomia after radiotherapy
• ≥18 years
• Irradiated with radiotherapy in the major salivary glands (parotid, submandibular and sublingual)
• Grade 3 for dry mouth in Common Terminology Criteria for Adverse Events, CTCAE (version 5.0)
• Have completed medical treatment with full response (complete remission) and receive medical clearance for participation.
• At least one month after radiotherapy completion, to reflect the possible presence of oral mucositis (sores) and/or radiodermatitis (inflammation) that limits adherence to treatment
• No use of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers or herbs) to prevent or treat xerostomia before inclusion in the study, OR constant usage (do not change type and dosage) during 2 months before inclusion in the study

Exclusion Criteria:

• Relapse or metastasis
• Karnofsky activity scale <60
• Contraindications to PBM therapy (cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, pregnancy)
• Patients with other comorbidities such as diabetes o polymedication