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

Study Overview
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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).

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.

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

Conditions
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Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia

Intervention / Treatment
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* Device: Energy density photobiomodulation (7.5)
* Device: Sham placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBM group<br>Energy density 7.5 J / cm2 | Device: Energy density photobiomodulation (7.5)<br>* A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).<br>|
| Placebo Comparator: Control group<br>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. | Device: Sham placebo<br>* A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Xerostomia severity. | Xerostomia Inventory consists of 11 items, the total score ranges from 11 to 55 points, and represents the severity of chronic xerostomia. Higher scores mean a worse outcome. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Salivary flow rate. | Determines the amount of unstimulated saliva (ml) produced in 3 minutes. Higher amount means less hyposalivation. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| General and specific quality of life in patients with head and neck cancer. | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 assesses overall quality of life. It is a valid questionnaire and widely used in cancer population. High score for functional scales and global health status represents better outcomes. Higher symptom scales/items scores mean a worse outcome. In addition, its specific head and neck module (EORTC QLQ-H&N35) where higher symptom scales/items scores mean a worse outcome. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Nutritional and oral status. | Assesses through a Eating Assessment Tool questionnaire (EAT-10). Higher scores mean a worse outcome. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Maximum mouth opening. | Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper. More distance means better mobility. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold. | Using a digital algometer in C5-C6 joint, upper trapezius, levator scapulae, masseter, temporalis, sternoclavicular joint and the tibialis anterior (distal point). Higher values mean higher pain pressure threshold. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Fitness Scale. | The International Fitness Scale (IFIS) assesses overall fitness, cardio-respiratory, muscular, speed and flexibility dimensions using a 5-point Likert scale ('very poor', 'poor', 'average', 'good' and 'very good'). Higher scores mean a better outcome. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Mood status. | The Spanish version of the Scale for Mood Assessment (EVEA) assesses mood state with a range of 0 to 10. It consists of 4 subscales: sadness-depression, anxiety, anger-hostility and happiness. Higher scores mean a worse outcome. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Quality of sleep. | The Pittsburgh Sleep Quality Index will be used to evaluate the perceived quality of sleep in its Spanish version. Higher scores mean a worse outcome. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Physical activity level. | The International Physical Activity Questionnaire (IPAQ-SF) is a tool that it will be used to evaluate physical activity. Different types of physical activities will be recorded (walking, moderate intensity activities, and vigorous intensity activities) during the last 7 days. More time means more amount of physical activity. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Functional capacity. | Using walked distance (m) during 6-minutes walking test. Longer distance means better outcome. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 
| Risk of falls. | Using time (s) during Test Up and Go (TUG). Less time means less risk of falls. | Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Quality of Life, Xerostomia, Low-Level Light Therapy