Back to resultsPhotobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy
Primary Purpose
Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Energy density photobiomodulation (7.5)
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
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 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 Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PBM group
Control group
Arm Description
Energy density 7.5 J / cm2
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.
Outcomes
Primary Outcome Measures
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.
Salivary flow rate.
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.
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.
Nutritional and oral status.
Assesses through a Eating Assessment Tool questionnaire (EAT-10). Higher scores mean a worse outcome.
Maximum mouth opening.
Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper. More distance means better mobility.
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). Higher values mean higher pain pressure threshold.
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. More time means more amount of physical activity.
Functional capacity.
Using walked distance (m) during 6-minutes walking test. Longer distance means better outcome.
Risk of falls.
Using time (s) during Test Up and Go (TUG). Less time means less risk of falls.
Full Information
NCT ID
NCT05614843
First Posted
November 6, 2022
Last Updated
October 9, 2023
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT05614843
Brief Title
Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy
Official Title
Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
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
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.
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
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 two 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
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBM group
Arm Type
Experimental
Arm Description
Energy density 7.5 J / cm2
Arm Title
Control group
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 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.
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).
Intervention Type
Device
Intervention Name(s)
Sham placebo
Intervention Description
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).
Primary Outcome Measure Information:
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
Salivary flow rate.
Description
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).
Title
General and specific quality of life in patients with head and neck cancer.
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. 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).
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
Maximum mouth opening.
Description
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).
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). Higher values mean higher pain pressure threshold.
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. More time means more amount of physical activity.
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. Longer distance means better outcome.
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). Less time means less risk of falls.
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 our study (unrelated, possibly related, or related to the study) using Common Terminology Criteria for adverse events (version 5.0). Higher scores mean a worse outcome.
Time Frame
12 weeks (after intervention).
Title
Satisfaction questionnaire.
Description
Each patient will mark his/her experience after PBM therapy. Higher scores mean a better outcome.
Time Frame
12 weeks (after intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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
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
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
18016
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy
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