Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: L3AXER Study
Study Details
Study Description
Brief Summary
The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Many experts advocate the use of Photobiomodulation (PBM) therapy in patients with cancer and demand studies of higher methodological quality such as randomized controlled clinical trials. However, there is no consensus on the most effective dosimetry that allows us to establish an effective and safe approach to treat radiotherapy-induced xerostomia in head and neck cancer survivors. Finally, recent reviews highlight the importance of determining whether or not the effects of Photobiomodulation therapy are maintained after a follow-up period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group PBM_1 Energy density 7.5 J / cm2 for group PBM_1 |
Device: 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). In addition, a mobile health application (L3AXER) will be provided.
|
| Experimental: Group PBM_2 Energy density 3 J / cm2 for group PBM_2 |
Device: Energy density photobiomodulation (3)
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (L3AXER) will be provided.
|
| Placebo Comparator: Placebo Control The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective glasses) using the same laser device to imitate a real irradiation; however, the device will be turned off and a recording of the emission sounds will be used to give the patient the hearing sensation of the laser therapy. |
Device: Sham placebo
In addition, a mobile health application (L3AXER) will be provided.
|
Outcome Measures
Primary Outcome Measures
- General and specific quality of life in head and neck cancer patients. [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. Higher symptom scales/items and global health status scores mean worse and better outcomes, respectively. It is a valid questionnaire and widely used in cancer population. In addition, its specific head and neck module (EORTC QLQ-H & N35). Higher symptom scales/items scores mean a worse outcome.
- 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.
- Visual Analogue Scale (VAS) for xerostomia and cervical/temporomandibular/shoulder pain [Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).]
The subjective perception of xerostomia/pain from 0 to 10 will be registered. 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 stimulated and unstimulated saliva (ml) produced in 3 minutes.
- Indicators of saliva [Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).]
Quality of saliva with salivary biomarkers of salivary pH and cortisol, IgA, IL6, calcium, total protein, chloride, sodium / potassium and amylase / catalase activities using different laboratory kits.
- Glandular ultrasound [Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).]
It will monitor the morphology (size, echogeneity etc.) of the glands using ultrasound (Samsung HM70A echograph and Samsung Phased Array PE2-4 probe).
- 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.
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
Other Outcome Measures
- Safety and adverse events [Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).]
Each adverse event is characterized by severity (grade 1 [mild] to 5 [death]), expectation (expected or unexpected) and potential relationship with participation in the study (unrelated, possibly related, or related to the study) using Common Terminology Criteria for adverse events (version 5.0).
- Satisfaction questionnaire [12 weeks (after intervention)]
Each patient will mark his/her experience after Photobiomodulation therapy and L3AXER app. Higher scores mean a better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with head and neck cancer
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Persistent xerostomia after radiotherapy
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≥18 years
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Irradiated with radiotherapy in the major salivary glands (parotid, submandibular and sublingual)
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Grade 3 for dry mouth in Common Terminology Criteria for Adverse Events, CTCAE (version 5.0)
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Have completed medical treatment with full response (complete remission) and receive medical clearance for participation.
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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
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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:
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Relapse or metastasis
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Karnofsky activity scale <60
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Contraindications to PBM therapy (cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, pregnancy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Health Sciences | Granada | Spain | 18070 |
Sponsors and Collaborators
- Universidad de Granada
Investigators
- Principal Investigator: Noelia Galiano-Castillo, PhD, Universidad de Granada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PBM_CANCER21
- PI-0187-2021