NCT Number: NCT05106608
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Granada, 18070, Spain
Location status: Recruiting
Elisa Paula Postigo-Martin, MsC
SUB_INVESTIGATOR
Maria de la Cabeza Lopez-Garzon, MsC
SUB_INVESTIGATOR
Mario Lozano-Lozano, PhD
SUB_INVESTIGATOR
Noelia Galiano-Castillo, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients will be included in the study if they meet the following inclusion criteria:
The exclusion criteria will be as follows:
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.
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.
In addition, a mobile health application (LAXER) will be provided.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) 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 comprises 30 items on 5 functional scales, 3 symptom scales, 6 single items and a global health scale measured by a 4-point Likert scale with a total score ranging from 0 to 100. Higher scores on the functional and global health scales indicate better functioning or QoL, respectively, but higher scores on the symptom scales or single items indicate a high level of symptoms. In addition, the specific head and neck module (EORTC QLQ-H&N35) will be used; this module comprises 35 items on 7 multi-item scales and 11 single items scored from 0 to 100. Higher scores indicate more symptoms.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Xerostomia Inventory consists of 11 items (score range 1-5) with a total score ranging from 11 to 55 points to rate the severity of chronic xerostomia. A higher score indicates more severe xerostomia.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Eating Assessment Tool questionnaire (EAT-10) consists of 10 items related to swallowing difficulties (score range 0-4, 0=no problem, 4=severe problem), with a total score of 3 or higher indicating dysphagia.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
A numeric visual analog scale (VAS) will be used with with a grade ranging from 0 (no symptoms) to 10 (the worst possible symptoms).
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The degree of mouth opening will be determined by the range of motion (ROM) using a sliding caliper, which will measure the maximal interincisal distance in millimeters.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
A total of 10 examples of clinical physical findings where each one represents a feature of dryness in the mouth will be administered through the Clinical Oral Dryness Score (CODS). A score of 2 or more indicates significant oral dryness.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Regional Oral Dryness Inventory (RODI) quantifies the severity of dryness at 9 different locations in the oral cavity and is represented by 9 illustrations. Patients will indicate the severity of perceived oral dryness using a 5-point Likert scale (1=none, 5=severe).
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The 5-min unstimulated and 5-min stimulated salivary flow rates (SFRs) will be calculated (ml/min) and the volume of each sample will be also calculated (in microlitres). Samples from unstimulated saliva will be used to analyse salivary biomarkers, such as proteins (e.g., antibodies), calcium concentration and pH, using commercial kits.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The morphology of the parotid and submandibular glands will be assessed using 2D echography (Samsung HM70A echograph) to quantify changes in size in three dimensions.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
An electronic algometer (SENSEBox System, Somedic AB, Sösdala, SE) will be used to assess pain at 7 body sites bilaterally: the C5-C6 joint, upper trapezius, elevator scapulae, masseter, temporalis, sternoclavicular joint and tibialis anterior distal point. The mean of the three measurements will be considered.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The 6-minute walk test (6MWT) will be used; the maximum walked distance (meters) that patients are able to walk in a 30-meter linear corridor will be quantified. A longer distance indicates better functional capacity.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The timed up-and-go (TUG) test will be used; patients sit back in a chair and walk toward a cone located 3 meters away as quickly as possible. The time (seconds) needed will be registered 2 times, with a shorter time indicating better mobility.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The International Fitness Scale (IFIS) assesses overall fitness, cardio-respiratory fitness, muscular strength, speed/agility and flexibility dimensions, using a 5-point Likert scale (1=very poor, 2=poor, 3=average, 4=good, 5=very good).
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The International Physical Activity Questionnaire Short Form (IPAQ-SF), a self-reported validated questionnaire in patients with cancer that records the activities of the previous 7 days according to intensity level.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The Spanish version of the Scale for Mood Assessment (EVEA) will also be used and comprises 4 subscales with good reliability (sadness-depression, anxiety, anger-hostility and happiness); the items range from 0 to 10 (0=nothing, 10=much).
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that includes 19 self-related questions ranging from 0 to 3. The total score ranges from 0 to 21, and a lower score indicates better quality of sleep.
Time frame: 12 weeks (postintervention)
Safety will be assessed by the occurrence of any AEs using CTCAE version 5.0.
Time frame: 12 weeks (postintervention)
Satisfaction will be registered by a questionnaire previously used in other clinical settings at the end of the intervention.
Contact information is provided by the study sponsor or research team.
Universidad de Granada
Other
Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study
Acronym: LAXER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05614843
Head and Neck Cancer, Head and Neck Neoplasms
Granada, Spain
View Trial DetailsNCT04075305
Bladder Cancer, Bladder Neoplasm
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06465628
Head and Neck Cancer, Head and Neck Neoplasms
Hong Kong
View Trial DetailsNCT06662929
Carcinoma, Carcinoma, Squamous Cell
Riyadh, Saudi Arabia
View Trial Details