Oral Mucositis Clinical Trial
Official title:
Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia
Introduction: Oral mucositis is one of the most frequent complications associated with chemotherapy, occurring in up to 90% children receiving treatment for cancer. Different treatment modalities have been suggested with inconsistent results. Recently, it has been suggested that the use of laser could reduce the grade of oral mucositis and alleviate the symptoms. Aim: To evaluate and compare the efficacy between the high (Infrared) wavelength laser and low (red) wavelength laser in management of chemotherapy induced oral mucositis in children with acute lymphoblastic leukemia. Methods: This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups. Group I: will be treated with Laser wavelength 660 nm, group II: will be treated with laser wavelength 970 nm, and group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission. All the patients will follow the hospital standard management for oral mucositis. All patients will be assessed for pain score using CHIMES, oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. As well as measuring the duration of the lesion.
This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14 years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups. Group I: will be treated with Laser wavelength 660 nm, Group II: will be treated with laser wavelength 970 nm, Group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission. All the patients will follow the hospital standard management for oral mucositis. All patients will be assessed for 1. Pain score using CHIMES, 2. Oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. 3. Measuring the duration of the lesion. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02229136 -
Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
|
Phase 2 | |
| Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
| Enrolling by invitation |
NCT02662374 -
Oral Hygiene Regimen in Patients on HCT
|
Phase 4 | |
| Completed |
NCT00938080 -
Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck
|
Phase 1 | |
| Completed |
NCT00756951 -
Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00701688 -
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1 | |
| Not yet recruiting |
NCT05059613 -
Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
|
N/A | |
| Completed |
NCT04440930 -
White Tea for Prevention of Chemotherapy Induced Mucositis
|
N/A | |
| Completed |
NCT05705622 -
The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients
|
N/A | |
| Completed |
NCT02399228 -
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis
|
Phase 2 | |
| Withdrawn |
NCT02589860 -
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
|
||
| Active, not recruiting |
NCT01772706 -
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer
|
N/A | |
| Enrolling by invitation |
NCT06122636 -
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC
|
N/A | |
| Completed |
NCT03689712 -
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
|
Phase 3 | |
| Terminated |
NCT02539342 -
Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy
|
Phase 3 | |
| Completed |
NCT02555501 -
Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy
|
Phase 3 | |
| Completed |
NCT01789658 -
Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
|
N/A | |
| Completed |
NCT00790322 -
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
|
Phase 3 | |
| Recruiting |
NCT00549952 -
Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients
|
N/A | |
| Completed |
NCT00289003 -
The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients
|
Phase 2 |