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

University of Granada (UGR)

Status: Completed

Conditions: Xerostomia; Head and Neck Neoplasms; Head and Neck Cancer

Treatments: Device: Sham placebo; Device: Energy density photobiomodulation (7.5)

Study type: Interventional

Funder types: Other

Identifiers

NCT05614843

PI-0187-2021 (Other Grant/Funding Number)

PPJIA2020-15 (Other Grant/Funding Number)

PBM_CANCER

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

PBM group

Experimental group

Description:

Energy density 7.5 J / cm2

Treatment:

Device: Energy density photobiomodulation (7.5)

Control group

Placebo Comparator group

Description:

The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective goggles) using the same laser device to imitate a real irradiation; however, the device will be turned off and recording of the emission sounds will be used to give the patient the hearing sensation of the PBM therapy.

Treatment:

Device: Sham placebo