LI-TASTE Study: Light for Taste (LI-TASTE)

February 13, 2024 updated by: Academic Centre for Dentistry in Amsterdam

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • THOR Oral LED
Sham Comparator: 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.
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.
Other Names:
  • THOR Oral LED Sham Setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academic Centre for Dentistry in Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 29, 2024

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL84772.018.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on LX2.3 Laser and LED Photobiomodulation System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe