Back to resultsPhotobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study (LAXER)
Primary Purpose
Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Energy density photobiomodulation (7.5)
Energy density photobiomodulation (3)
Sham placebo
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Quality of Life, Neoplasms, Xerostomia, Low-Level Light Therapy, Telemedicine
Eligibility Criteria
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.
- Be able to access mobile apps or living with someone who has this ability.
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.
Sites / Locations
- Faculty of Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group PBM_1
Group PBM_2
Placebo Control
Arm Description
Energy density 7.5 J / cm2 for group PBM_1
Energy density 3 J / cm2 for group PBM_2
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.
Outcomes
Primary Outcome Measures
General and specific quality of life in head and neck cancer patients.
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.
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.
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
The subjective perception of xerostomia/pain from 0 to 10 will be registered. Higher scores mean a worse outcome.
Salivary flow rate
Determines the amount of stimulated and unstimulated saliva (ml) produced in 3 minutes.
Indicators of saliva
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
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
Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Functional capacity
Using walked distance (m) during 6-minutes walking test.
Risk of falls
Using time (s) during Test Up and Go (TUG).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05106608
Brief Title
Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
Acronym
LAXER
Official Title
Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
Keywords
Quality of Life, Neoplasms, Xerostomia, Low-Level Light Therapy, Telemedicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Participants who meet the inclusion and exclusion criteria will be randomized to one of the three 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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group PBM_1
Arm Type
Experimental
Arm Description
Energy density 7.5 J / cm2 for group PBM_1
Arm Title
Group PBM_2
Arm Type
Experimental
Arm Description
Energy density 3 J / cm2 for group PBM_2
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Energy density photobiomodulation (7.5)
Intervention Description
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 (LAXER) will be provided.
Intervention Type
Device
Intervention Name(s)
Energy density photobiomodulation (3)
Intervention Description
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 (LAXER) will be provided.
Intervention Type
Device
Intervention Name(s)
Sham placebo
Intervention Description
In addition, a mobile health application (LAXER) will be provided.
Primary Outcome Measure Information:
Title
General and specific quality of life in head and neck cancer patients.
Description
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.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Xerostomia severity.
Description
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).
Title
Nutritional and oral status.
Description
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).
Title
Visual Analogue Scale (VAS) for xerostomia and cervical/temporomandibular/shoulder pain
Description
The subjective perception of xerostomia/pain from 0 to 10 will be registered. Higher scores mean a worse outcome.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Salivary flow rate
Description
Determines the amount of stimulated and unstimulated saliva (ml) produced in 3 minutes.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Indicators of saliva
Description
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.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Glandular ultrasound
Description
It will monitor the morphology (size, echogeneity etc.) of the glands using ultrasound (Samsung HM70A echograph and Samsung Phased Array PE2-4 probe).
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Maximum mouth opening
Description
Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
Using a digital algometer in C5-C6 joint, upper trapezius, levator scapulae, masseter, temporalis, sternoclavicular joint and the tibialis anterior distal point.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Fitness Scale
Description
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).
Title
Mood status
Description
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).
Title
Quality of sleep
Description
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).
Title
Physical activity level
Description
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.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Functional capacity
Description
Using walked distance (m) during 6-minutes walking test.
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Risk of falls
Description
Using time (s) during Test Up and Go (TUG).
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Other Pre-specified Outcome Measures:
Title
Safety and adverse events
Description
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).
Time Frame
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Title
Satisfaction questionnaire
Description
Each patient will mark his/her experience after Photobiomodulation therapy and LAXER app. Higher scores mean a better outcome.
Time Frame
12 weeks (after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Be able to access mobile apps or living with someone who has this ability.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noelia Galiano-Castillo, PhD
Phone
699197690
Ext
+34
Email
noeliagaliano@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noelia Galiano-Castillo, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences
City
Granada
ZIP/Postal Code
18070
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelia Galiano-Castillo, PhD
First Name & Middle Initial & Last Name & Degree
Maria de la Cabeza Lopez-Garzon, MsC
First Name & Middle Initial & Last Name & Degree
Elisa Paula Postigo-Martin, MsC
First Name & Middle Initial & Last Name & Degree
Mario Lozano-Lozano, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available upon reasonable request. IPD that underlie the results reported in the future article/s, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.
Learn more about this trial
Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
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