LI-TASTE Study: Light for Taste

Multiple Myeloma Clinical Trial

— LI-TASTE  

Official title:

Photobiomodulation Therapy, a Novel Approach for the Management of Taste Disorders in Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258096
• Other study ID #: NL84772.018.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: February 2024
• Source: Academic Centre for Dentistry in Amsterdam
• Contact: Alexa Laheij, dr.
• Phone: 020-5980527
• Email: a.laheij[@]acta.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: January 30, 2025
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with a haematological malignancy

• > 18 years of age

• Receiving HDM followed by SCT

• Able and willing to give informed consent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Device:
• LX2.3 Laser and LED Photobiomodulation System
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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academic Centre for Dentistry in Amsterdam

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks
Secondary	Salivary flow	the presence and severity of hyposalivation following SCT	6 weeks
Secondary	Xerostomia	the presence and severity of xerostomia following SCT	6 weeks
Secondary	Oral mucositis	the presence and severity of patient reported oral mucositis following SCT	6 weeks
Secondary	Caloric intake	the caloric intake before and after SCT	6 weeks
Secondary	Global-health-related QoL	Global Qol will be assessed by EORTC QLQ-C30 (Version 3.0)	3 weeks
Secondary	Oral-health-related QoL	Oral-health related QoL will be assessed by EORTC QLQ - OH15	3 weeks