Multiple MyelomaLI-TASTENCT06258096
LI-TASTE Study: Light for Taste
A study testing LX2.3 Laser and LED Photobiomodulation System in people with Multiple Myeloma, run by Academic Centre for Dentistry in Amsterdam.
Trial summary
Rationale: In 2020, 115,000 Dutch patients were diagnosed with cancer. Up to 85% of patients treated with radiotherapy involving the head and neck, chemotherapy or stem-celltransplantation (SCT) suffer from taste disorders (dysgeusia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- LX2.3 Laser and LED Photobiomodulation System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients diagnosed with a haematological malignancy
- > 18 years of age
- Receiving HDM followed by SCT
- Able and willing to give informed consent
Who cannot join
- Having taste disorders not related to SCT (e.g. COVID-19)
- History of a head and neck tumor treated with surgery and/or (chemo)radiation
- Neurological diseases (e.g. Parkinson's disease)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Photobiomodulation Therapy, a Novel Approach for the Management of Taste Disorders in Cancer Patients
Rationale: In 2020, 115,000 Dutch patients were diagnosed with cancer. Up to 85% of patients treated with radiotherapy involving the head and neck, chemotherapy or stem-celltransplantation (SCT) suffer from taste disorders (dysgeusia). Dysgeusia is one of the most distressing adverse effects of cancer therapy, may be long-lasting and may contribute to malnutrition and decreased QoL. Dysgeusia pathobiology is complex and relates to direct damage to taste buds by anticancer therapies, neuropathy and/or mucosal infection and inflammation. Hyposalivation and concurrent medications may also play a role as well as smoking and poor oral health. Zinc suppletion, clonazepam and delta-9-tetrahydrocannabionol have only limited success. Thus, dysgeusia in cancer patients represents a significant unmet clinical need.
Photobiomodulation therapy (PBMT) using specific wavelengths of red/near infrared light reduces oxidative stress and increases ATP in cells, which improves cell metabolism and reduces inflammation. PBMT is safe and effective for the prevention of oral mucositis and is linked to pain reduction, nerve damage recovery and improved wound healing. There is emerging evidence for PBMT to improve taste, likely based on its regenerative effects on taste buds and nerves involved in taste function. However, there is need for more reliable data on the effect of PBMT on taste. Objective: Assess the efficacy of PBMT to prevent/ameliorate dysgeusia in patients with multiple myeloma treated in Amsterdam UMC with conditioning chemo(radio)therapy followed by autologous stem-cell-transplantation.
Read more
Study design: Single centre, prospective, longitudinal, double-blinded, randomized, controlled study. Study population: Recipients of autologous hematopoietic stem cell transplantation (SCT) for the treatment of multiple myeloma in Amsterdam UMC. Intervention: Patients will be blinded to receive either PBMT or sham-PBMT. Main study parameters/endpoints: Objective and subjective taste function and taste associated covariables and their impact on QoL will be assessed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The application of PBMT to the (peri)oral region is safe and comes with no relevant side effects. The application of PBMT or sham-PBMT will take about 10-15 minutes per treatment. The measurements at the start of the study and at the visit six weeks after SCT will last about 30 minutes. Scoring the PROMS (2 questionnaires of 1-5 questions) during hospitalization will take about five minutes per day; 2 questionnaires (30+15+ 5 questions), 10 minutes, weekly. Patients do not need to come to the hospital specifically for the study, as they already have an appointment in the hospital.
- Conditions
- Multiple Myeloma
- Being tested
- LX2.3 Laser and LED Photobiomodulation System, LX2.3 Laser and LED Photobiomodulation System Sham-PBMT Setting
- Keywords
- Stemcell transplant, Light therapy, Taste changes, Dysgeusia
- Medical subject headings
- Multiple Myeloma, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX2.3 Laser and LED Photobiomodulation SystemDevice
Also called THOR Oral LED
The LX2.3 Laser and LED Photobiomodulation system by THOR Photomedicine Ltd is a CE marked product and has a long track record of safety, usability, and effectiveness.
LX2.3 Laser and LED Photobiomodulation System Sham-PBMT SettingDevice
Also called THOR Oral LED Sham Setting
The sham setting consists of light of the same colour (white light with a red filter), applied in the same way as in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation therapy (PBMT) | Experimental | Patients will receive either PBMT or sham-PBMT during admission to the hospital. The oral cavity of the patients will be exposed to LED light using a new intra-oral device on the THOR Control Unit at the intensity of 50mW/m2 for 60 seconds per dose. Additionally, the perioral region will be exposed to LED light using an extra-oral device on the THOR Control Unit at the intensity of 50mW/m2 for 60 seconds per dose. Receives: Device: LX2.3 Laser and LED Photobiomodulation System |
| Sham-PBMT | Sham comparator | Patients will receive either PBMT or sham-PBMT during admission to the hospital. The sham-PBMT is the placebo treatment and consists of light of the same colour (white light with a red filter), applied in the same way as in the experimental group. Receives: Device: LX2.3 Laser and LED Photobiomodulation System Sham-PBMT Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively scored taste changes
The Medisense test will be used to assess objective taste: The ODOFIN taste strips are a validated research procedure for determining taste sensitivity. The patient's task is to choose one of the following answers: 1. Sweet, 2. Sour, 3. Salty, 4. Bitter, 5. Umami, 6. No taste. The maximum number of points is 4 points per taste.
Measured: 6 weeks
Subjectively scored taste changes
The CiTAS-NL questionnaire will be used to assess subjective taste: Decline in basic tastes: Add up the scores of questions 2 to 6 and divide by 5. Discomfort: Add up the scores of questions 13 to 18 and divide by 6. Phantogeusia or parageusia: Add up the scores of questions 10 to 12 and divide by 3. General taste changes: Add up the scores of question 1 and from 7 to 9 and divide by 4. Overall score: Add up the scores from question 1 to 18 and divide by 18. Interpretation of score: A score lower than 6 is not significant, 6-10 indicates mild, 10-14 indicates moderate, and 15-20 indicates severe taste changes.
Measured: 6 weeks
Secondary outcomes (6)
Salivary flow
the presence and severity of hyposalivation following SCT
Measured: 6 weeks
Xerostomia
the presence and severity of xerostomia following SCT
Measured: 6 weeks
Oral mucositis
the presence and severity of patient reported oral mucositis following SCT
Measured: 6 weeks
Caloric intake
the caloric intake before and after SCT
Measured: 6 weeks
Global-health-related QoL
Global Qol will be assessed by EORTC QLQ-C30 (Version 3.0)
Measured: 3 weeks
Oral-health-related QoL
Oral-health related QoL will be assessed by EORTC QLQ - OH15
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start29 Feb 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academic Centre for Dentistry in Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258096
- Sponsor's protocol ID
- NL84772.018.23
- Acronym
- LI-TASTE
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy, a Novel Approach for the Management of Taste Disorders in Cancer Patients
- ClinicalTrials.gov ID
- NCT06258096
- Acronym / sponsor ID
- LI-TASTE / NL84772.018.23
- Conditions
- Multiple Myeloma
- Keywords
- Stemcell transplant, Light therapy, Taste changes, Dysgeusia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Academic Centre for Dentistry in AmsterdamUniversity, hospital or other
- Study start
- 29 Feb 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 14 Feb 2024 (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.
Rationale: In 2020, 115,000 Dutch patients were diagnosed with cancer. Up to 85% of patients treated with radiotherapy involving the head and neck, chemotherapy or stem-celltransplantation (SCT) suffer from taste disorders (dysgeusia). Dysgeusia is one of the most distressing adverse effects of cancer therapy, may be long-lasting and may contribute to malnutrition and decreased QoL. Dysgeusia pathobiology is complex and relates to direct damage to taste buds by anticancer therapies, neuropathy and/or mucosal infection and inflammation. Hyposalivation and concurrent medications may also play a role as well as smoking and poor oral health. Zinc suppletion, clonazepam and delta-9-tetrahydrocannabionol have only limited success. Thus, dysgeusia in cancer patients represents a significant unmet clinical need.
Photobiomodulation therapy (PBMT) using specific wavelengths of red/near infrared light reduces oxidative stress and increases ATP in cells, which improves cell metabolism and reduces inflammation. PBMT is safe and effective for the prevention of oral mucositis and is linked to pain reduction, nerve damage recovery and improved wound healing. There is emerging evidence for PBMT to improve taste, likely based on its regenerative effects on taste buds and nerves involved in taste function. However, there is need for more reliable data on the effect of PBMT on taste. Objective: Assess the efficacy of PBMT to prevent/ameliorate dysgeusia in patients with multiple myeloma treated in Amsterdam UMC with conditioning chemo(radio)therapy followed by autologous stem-cell-transplantation.
Study design: Single centre, prospective, longitudinal, double-blinded, randomized, controlled study. Study population: Recipients of autologous hematopoietic stem cell transplantation (SCT) for the treatment of multiple myeloma in Amsterdam UMC. Intervention: Patients will be blinded to receive either PBMT or sham-PBMT. Main study parameters/endpoints: Objective and subjective taste function and taste associated covariables and their impact on QoL will be assessed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The application of PBMT to the (peri)oral region is safe and comes with no relevant side effects. The application of PBMT or sham-PBMT will take about 10-15 minutes per treatment. The measurements at the start of the study and at the visit six weeks after SCT will last about 30 minutes. Scoring the PROMS (2 questionnaires of 1-5 questions) during hospitalization will take about five minutes per day; 2 questionnaires (30+15+ 5 questions), 10 minutes, weekly. Patients do not need to come to the hospital specifically for the study, as they already have an appointment in the hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind RCT
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation therapy (PBMT) | Experimental | Device: LX2.3 Laser and LED Photobiomodulation SystemPatients will receive either PBMT or sham-PBMT during admission to the hospital. The oral cavity of the patients will be exposed to LED light using a new intra-oral device on the THOR Control Unit at the intensity of 50mW/m2 for 60 seconds per dose. Additionally, the perioral region will be exposed to LED light using an extra-oral device on the THOR Control Unit at the intensity of 50mW/m2 for 60 seconds per dose. |
| Sham-PBMT | Sham comparator | Device: LX2.3 Laser and LED Photobiomodulation System Sham-PBMT SettingPatients will receive either PBMT or sham-PBMT during admission to the hospital. The sham-PBMT is the placebo treatment and consists of light of the same colour (white light with a red filter), applied in the same way as in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with a haematological malignancy
- > 18 years of age
- Receiving HDM followed by SCT
- Able and willing to give informed consent
Key exclusion criteria (3 listed)
- Having taste disorders not related to SCT (e.g. COVID-19)
- History of a head and neck tumor treated with surgery and/or (chemo)radiation
- Neurological diseases (e.g. Parkinson's disease)
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 |
|---|---|---|
| LX2.3 Laser and LED Photobiomodulation SystemAlso: THOR Oral LEDThe LX2.3 Laser and LED Photobiomodulation system by THOR Photomedicine Ltd is a CE marked product and has a long track record of safety, usability, and effectiveness. | Device | Photobiomodulation therapy (PBMT) |
| LX2.3 Laser and LED Photobiomodulation System Sham-PBMT SettingAlso: THOR Oral LED Sham SettingThe sham setting consists of light of the same colour (white light with a red filter), applied in the same way as in the experimental group. | Device | Sham-PBMT |
Primary outcome
Objectively scored taste changes
Time frame: 6 weeks
The Medisense test will be used to assess objective taste: The ODOFIN taste strips are a validated research procedure for determining taste sensitivity. The patient's task is to choose one of the following answers: 1. Sweet, 2. Sour, 3. Salty, 4. Bitter, 5. Umami, 6. No taste. The maximum number of points is 4 points per taste.
Subjectively scored taste changes
Time frame: 6 weeks
The CiTAS-NL questionnaire will be used to assess subjective taste: Decline in basic tastes: Add up the scores of questions 2 to 6 and divide by 5. Discomfort: Add up the scores of questions 13 to 18 and divide by 6. Phantogeusia or parageusia: Add up the scores of questions 10 to 12 and divide by 3. General taste changes: Add up the scores of question 1 and from 7 to 9 and divide by 4. Overall score: Add up the scores from question 1 to 18 and divide by 18. Interpretation of score: A score lower than 6 is not significant, 6-10 indicates mild, 10-14 indicates moderate, and 15-20 indicates severe taste changes.
6 secondary outcomes
Salivary flow
Time frame: 6 weeks
Xerostomia
Time frame: 6 weeks
Oral mucositis
Time frame: 6 weeks
Caloric intake
Time frame: 6 weeks
Global-health-related QoL
Time frame: 3 weeks
Oral-health-related QoL
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing LX2.3 Laser and LED Photobiomodulation System in people with Multiple Myeloma, run by Academic Centre for Dentistry in Amsterdam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexa Laheij, dr. (020-5980527, a.laheij@acta.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively scored taste changes (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.