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

Not Applicable

Completed

• Conditions: Xerostomia; Head and Neck Cancer; Head and Neck Neoplasms
• Interventions: Device: Energy density photobiomodulation (7.5); Device: Sham placebo

• Registration Number: NCT05614843
• Lead Sponsor: Universidad de Granada

Brief Summary

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

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 Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-14
• Primary Completion: 2023-02-28
• Study Completion: 2023-07-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBM group	Energy density photobiomodulation (7.5)	Energy density 7.5 J / cm2
Control group	Sham placebo	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.

Primary Outcome Measures

Name	Time	Method
Xerostomia severity.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	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.
Nutritional and oral status.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	Assesses through a Eating Assessment Tool questionnaire (EAT-10). Higher scores mean a worse outcome.
Salivary flow rate.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	Determines the amount of unstimulated saliva (ml) produced in 3 minutes. Higher amount means less hyposalivation.
General and specific quality of life in patients with head and neck cancer.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	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.
Maximum mouth opening.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper. More distance means better mobility.

Secondary Outcome Measures

Name	Time	Method
Fitness Scale.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	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.
Physical activity level.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	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.
Pressure pain threshold.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	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.
Mood status.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	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.
Functional capacity.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	Using walked distance (m) during 6-minutes walking test. Longer distance means better outcome.
Quality of sleep.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	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.
Risk of falls.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).	Using time (s) during Test Up and Go (TUG). Less time means less risk of falls.

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇪🇸 Granada, Spain