Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458517
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy During the Treatment of Head and Neck Cancers
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Institut de cancérologie Strasbourg Europe
Study Overview
Official Title:
Pilot Observational Study of Transcutaneous and Intraoral Photobiomodulation in the Prevention and Treatment of Radiomucositis in Head and Neck Cancers Treated by Radiotherapy - RADIO-PBM Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
RADIO-PBM
Brief Summary:
The aim of this feasibility prospective single-center trial is to compare an intra-oral Photobiomodulation PBM via the Caremin650TM device NeoMedLight and a transcutaneous PBM via the ATP 38 device Swiss Bio Innov in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity PBM session will be carried out first at the rate of two sessions per week for preventive purposes and then in case of occurence of grade 1 mucositis three sessions per week with curative purpose
Detailed Description:
Oral mucositis OM is defined as damage to the mucosa of the oral cavity it can be due to chemotherapy or radiotherapy The incidence of OM is 59 to 100 according to studies in patients with oral cavity or oropharyngeal cancer receiving radiotherapy
Clinically OM is characterized by erythematous changes in the mucosa which can progress to oral ulcerations It can significantly alter the quality of life the ability to eat cause weight loss in patients and interfere with the proper realization of anti-tumoral treatment Additionally OM may increase the risk of bacteremia and sepsis in immunocompromised patients
So far effective management strategies for OM and associated pain are still insufficient A wide variety of topical and oral agents are available but effectiveness is still lacking
Photobiomodulation PBM therapy involves the application of visible or infrared light produced by laser diodes or light-emitting diodes LEDs to stimulate wound healing reduce inflammation and decrease pain
PBM can be performed in two main ways intraoral and transcutaneous Intraoral PBM involves applying red or near-infrared light directly in contact with the oral mucosa while transcutaneous PBM involves the application of infrared radiation to the skin Both techniques have shown their effectiveness Numerous trials have evaluated the impact of PBM in radiomucositis but its use in clinical practice is to date not widespread and heterogeneous
Clinically OM is characterized by erythematous changes in the mucosa which can progress to oral ulcerations It can significantly alter the quality of life the ability to eat cause weight loss in patients and interfere with the proper realization of anti-tumoral treatment Additionally OM may increase the risk of bacteremia and sepsis in immunocompromised patients
So far effective management strategies for OM and associated pain are still insufficient A wide variety of topical and oral agents are available but effectiveness is still lacking
Photobiomodulation PBM therapy involves the application of visible or infrared light produced by laser diodes or light-emitting diodes LEDs to stimulate wound healing reduce inflammation and decrease pain
PBM can be performed in two main ways intraoral and transcutaneous Intraoral PBM involves applying red or near-infrared light directly in contact with the oral mucosa while transcutaneous PBM involves the application of infrared radiation to the skin Both techniques have shown their effectiveness Numerous trials have evaluated the impact of PBM in radiomucositis but its use in clinical practice is to date not widespread and heterogeneous
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