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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-07-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Head and Neck Cancer Head and Neck Neoplasms Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants who meet the inclusion and exclusion criteria will be randomized to one of the two study groups using a random number generation program (www.randomizer.org). The randomization sequence will be prepared by a member external to the investigation to respect the masking in terms of randomization of the participants, thus reducing the risk of bias during the evaluations. Therefore both patients and evaluator will be masked.

Study Groups

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PBM group

Energy density 7.5 J / cm2

Group Type EXPERIMENTAL

Energy density photobiomodulation (7.5)

Intervention Type DEVICE

A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).

Control group

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.

Group Type PLACEBO_COMPARATOR

Sham placebo

Intervention Type DEVICE

A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).

Interventions

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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).

Intervention Type DEVICE

Sham placebo

A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No