LI-TASTE Study: Light for Taste - Trial NCT06258096

Timeline & Enrollment

Primary Outcome

Objectively scored taste changes,Subjectively scored taste changes

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.

ICD-10 Classifications