Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258096
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-30
Brief Title:
LI-TASTE Study Light for Taste
Sponsor:
Academic Centre for Dentistry in Amsterdam
Organization:
Academic Centre for Dentistry in Amsterdam
Study Overview
Official Title:
Photobiomodulation Therapy a Novel Approach for the Management of Taste Disorders in Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LI-TASTE
Brief Summary:
Rationale In 2020 115000 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 andor 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 rednear 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 preventameliorate dysgeusia in patients with multiple myeloma treated in Amsterdam UMC with conditioning chemoradiotherapy 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 parametersendpoints 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 perioral 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 3015 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
Photobiomodulation therapy PBMT using specific wavelengths of rednear 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 preventameliorate dysgeusia in patients with multiple myeloma treated in Amsterdam UMC with conditioning chemoradiotherapy 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 parametersendpoints 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 perioral 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 3015 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None