Head and Neck CancerLAXERNCT05106608
Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
A study testing Energy density photobiomodulation (7.5) and Energy density photobiomodulation (3) in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
- What is being tested?
- Energy density photobiomodulation (7.5) and Energy density photobiomodulation (3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jul 2022to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients will be included in the study if they meet the following inclusion criteria:
- men or women aged 18 years or older and were diagnosed with HNC.
- chronic xerostomia.
- received RT in the parotid, submandibular and/or sublingual salivary glands.
- grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).
- medical treatment completed and in complete remission.
- received medical clearance for participation in this study.
- at least one month passed since the end of RT to avoid the possible presence of oral mucositis and/or radiodermatitis, which limits adherence to treatment and maximum 36 months.
- no history of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion.
- and able to access mobile applications or living with someone who has this ability.
The exclusion criteria will be as follows:
- patients with metastases.
- a score <60 on the Karnofsky Performance Status Scale.
- contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy).
- other comorbidities such as diabetes and polypharmacy.
- and retraction of the declaration of consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences
Granada, 18070
Noelia Galiano-Castillo, PhD
Maria de la Cabeza Lopez-Garzon, MsC
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
- Being tested
- Energy density photobiomodulation (7.5), Energy density photobiomodulation (3), Sham placebo
- Keywords
- Quality of Life, Neoplasms, Xerostomia, Low-Level Light Therapy, Telemedicine
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy density photobiomodulation (7.5)Device
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.
Energy density photobiomodulation (3)Device
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.
Sham placeboDevice
In addition, a mobile health application (LAXER) will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Group PBM_1 | Experimental | Energy density 7.5 J / cm2 for group PBM_1 Receives: Device: Energy density photobiomodulation (7.5) |
| Group PBM_2 | Experimental | Energy density 3 J / cm2 for group PBM_2 Receives: Device: Energy density photobiomodulation (3) |
| Placebo Control | Placebo comparator | 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. Receives: Device: Sham placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
General and specific quality of life.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Oral Health. Severity of xerostomia.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Oral Health. Dysphagia.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Oral Health. Perceived xerostomia.
A numeric visual analog scale (VAS) will be used with with a grade ranging from 0 (no symptoms) to 10 (the worst possible symptoms).
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Oral Health. Degree of mouth opening.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Oral Health. Clinical physical findings (dryness in the mouth).
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Oral Health. Regional oral dryness.
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).
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Salivary secretion.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Salivary gland ultrasound assessment.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Secondary outcomes (7)
Pressure pain threshold.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Functional capacity.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Mobility/fall risk.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Perceived fitness status.
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).
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Physical activity level.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Mood.
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).
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Sleep quality.
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.
Measured: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start13 Jul 2022
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia Galiano-Castillo, Universidad de Granada
- Investigators
- Noelia Galiano-Castillo, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106608
- Sponsor's protocol ID
- PBM_CANCER21
- Other IDs
- PI-0187-2021
- Acronym
- LAXER
- Status last verified
- Sep 2026
- First submitted
- 10 Oct 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Lozano-Lozano M, Lopez-Garzon M, Cuadrado-Guerrero P, Postigo-Martin P, Fernandez-Lao C, Tovar-Martin I, Galiano-Castillo N. Reliability of the electronic patient reported outcome measures for assessing xerostomia, dysphagia and quality of life in Spanish patients with head and neck cancer: a randomised crossover design. Health Qual Life Outcomes. 2025 Mar 3;23(1):19. doi: 10.1186/s12955-025-02347-1.
PubMed 40033397Lopez-Garzon M, Lopez-Fernandez MD, Ruiz-Martinez AM, Galvan-Banqueri P, Lozano-Lozano M, Tovar-Martin I, Postigo-Martin P, Ariza-Vega P, Artacho-Cordon F, Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-Gualda MA, Arroyo-Morales M, Ruiz-Villaverde R, Galiano-Castillo N. Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study. BMJ Open. 2024 Jan 24;14(1):e078068. doi: 10.1136/bmjopen-2023-078068.
PubMed 38267245
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05106608
- Acronym / sponsor ID
- LAXER / PBM_CANCER21
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
- Keywords
- Quality of Life, Neoplasms, Xerostomia, Low-Level Light Therapy, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group PBM_1 | Experimental | Device: Energy density photobiomodulation (7.5)Energy density 7.5 J / cm2 for group PBM_1 |
| Group PBM_2 | Experimental | Device: Energy density photobiomodulation (3)Energy density 3 J / cm2 for group PBM_2 |
| Placebo Control | Placebo comparator | Device: Sham placeboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 (LAXER) will be provided. | Device | Group PBM_1 |
| 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 (LAXER) will be provided. | Device | Group PBM_2 |
| Sham placeboIn addition, a mobile health application (LAXER) will be provided. | Device | Placebo Control |
Primary outcome
General and specific quality of life.
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.
Oral Health. Severity of xerostomia.
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.
Oral Health. Dysphagia.
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.
Oral Health. Perceived xerostomia.
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).
Oral Health. Degree of mouth opening.
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.
Oral Health. Clinical physical findings (dryness in the mouth).
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.
Oral Health. Regional 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).
Salivary secretion.
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.
Salivary gland ultrasound assessment.
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.
7 secondary outcomes
Pressure pain threshold.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Functional capacity.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Mobility/fall risk.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Perceived fitness status.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Functional Performance. Physical activity level.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Mood.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Sleep quality.
Time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 40033397Lozano-Lozano M, Lopez-Garzon M, Cuadrado-Guerrero P, Postigo-Martin P, Fernandez-Lao C, Tovar-Martin I, Galiano-Castillo N. Reliability of the electronic patient reported outcome measures for assessing xerostomia, dysphagia and quality of life in Spanish patients with head and neck cancer: a randomised crossover design. Health Qual Life Outcomes. 2025 Mar 3;23(1):19. doi: 10.1186/s12955-025-02347-1.
- Derived from this study: PubMed 38267245Lopez-Garzon M, Lopez-Fernandez MD, Ruiz-Martinez AM, Galvan-Banqueri P, Lozano-Lozano M, Tovar-Martin I, Postigo-Martin P, Ariza-Vega P, Artacho-Cordon F, Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-Gualda MA, Arroyo-Morales M, Ruiz-Villaverde R, Galiano-Castillo N. Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study. BMJ Open. 2024 Jan 24;14(1):e078068. doi: 10.1136/bmjopen-2023-078068.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noelia Galiano-Castillo, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy density photobiomodulation (7.5) and Energy density photobiomodulation (3) in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noelia Galiano-Castillo, PhD (699197690 ext. +34, noeliagaliano@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General and specific quality of life. (time frame: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05106608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.