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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).
Faculty of Health Sciences
Granada, Spain
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).