LI-TASTE Study: Light for Taste

NCT ID: NCT06258096

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-01-30

Brief 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Photobiomodulation therapy (PBMT)

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.

Group Type: EXPERIMENTAL

LX2.3 Laser and LED Photobiomodulation System

Intervention Type: DEVICE

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.

Sham-PBMT

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.

Group Type: SHAM_COMPARATOR

LX2.3 Laser and LED Photobiomodulation System Sham-PBMT Setting

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

THOR Oral LED; THOR Oral LED Sham Setting

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academic Centre for Dentistry in Amsterdam

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alexa Laheij, dr.

Role: CONTACT

a.laheij@acta.nl

020-5980527

Other Identifiers

NL84772.018.23

Identifier Type: -

Identifier Source: org_study_id