Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260111
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-01-26
Brief Title:
Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation
Sponsor:
Universidad del Desarrollo
Organization:
Universidad del Desarrollo
Study Overview
Official Title:
Laser Photobiomodulation to Prevent Oral Mucositis and Functional Impairment Among Adult Hematologic Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2024-07
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:
POMFITT
Brief Summary:
The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation HSCT The main questions it aims to answer are Is photobiomodulation with laser in the oral cavity compared to standard care effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT What is the level of patients acceptability of photobiomodulation with laser in the oral cavity during HSCT Participants once a day will receive photobiomodulation diode laser device in their oral cavity from the first day of transplantation conditioning until third day post-transplant Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment
Detailed Description:
Background Oral mucositis is a highly prevalent condition in individuals treated for hematologic neoplasms primarily during hematopoietic stem cell transplantation HSCT This condition delays the recovery process increasing infections interventions and hospital stays To date there are few experimental trials evaluating the use of photobiomodulation with laser for the management of oral mucositis and reporting its effect on functional outcomes in patients with hematologic cancer undergoing HSCT
Aim To evaluate the effectiveness and social acceptability of using photobiomodulation in the oral cavity to prevent mucositis and functional impairments in adult patients undergoing HSCT
Methods Randomized controlled clinical trial with parallel groups intervention group with photobiomodulation versus a control group assessor and statistician blinded Participants and setting 30 patients with hematologic neoplasms aged 18 to 65 undergoing HSCT at the Oncology and Bone Marrow Transplant Unit of Clínica Dávila Primary outcome measures Oral mucositis will be assessed on a daily basis with the World Health Organization Scale Functional capacity will be evaluated with a 2-minute static walking test handgrip strength using digital Jamar dynamometry lower limb strength with 30s Sits-and-Stand test and quality of life using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire Acceptability will be assessed by recording treatment adherence and a Visual Analog Scale Evaluations will be performed at two time points on admission to the transplant unit before the start of the conditioning regimen and on the day of hospital discharge Intervention Photobiomodulation will be delivered from the first day of conditioning until day 3 post-transplant A diode laser device with a wavelength of 660 nm an output power of 40 mW and an energy density of 4 Jcm2 measured at the end of the optical fiber with 004 cm2 of sectional area will be used The investigators expect that photobiomodulation prevents oral mucositis and enhance functional capacity muscle strength nutritional status and quality of life in patients with hematologic cancer undergoing bone marrow transplantation
Aim To evaluate the effectiveness and social acceptability of using photobiomodulation in the oral cavity to prevent mucositis and functional impairments in adult patients undergoing HSCT
Methods Randomized controlled clinical trial with parallel groups intervention group with photobiomodulation versus a control group assessor and statistician blinded Participants and setting 30 patients with hematologic neoplasms aged 18 to 65 undergoing HSCT at the Oncology and Bone Marrow Transplant Unit of Clínica Dávila Primary outcome measures Oral mucositis will be assessed on a daily basis with the World Health Organization Scale Functional capacity will be evaluated with a 2-minute static walking test handgrip strength using digital Jamar dynamometry lower limb strength with 30s Sits-and-Stand test and quality of life using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire Acceptability will be assessed by recording treatment adherence and a Visual Analog Scale Evaluations will be performed at two time points on admission to the transplant unit before the start of the conditioning regimen and on the day of hospital discharge Intervention Photobiomodulation will be delivered from the first day of conditioning until day 3 post-transplant A diode laser device with a wavelength of 660 nm an output power of 40 mW and an energy density of 4 Jcm2 measured at the end of the optical fiber with 004 cm2 of sectional area will be used The investigators expect that photobiomodulation prevents oral mucositis and enhance functional capacity muscle strength nutritional status and quality of life in patients with hematologic cancer undergoing bone marrow transplantation
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