Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Intervention1: Photobiomodulation therapy: Photobiomodulation therapy administered as an adjunct to standard supportive care in pediatric patients with chemotherapy induced oral mucositis using low le
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with hematolymphoid malignancies Patients aged between 3 and 14 years Patients currently receiving chemotherapy Patients presenting with chemotherapy induced oral mucositis of World Health Organization grade 2 or higher at the time of screening Patients for whom written informed consent is obtained from a parent or legal guardian along with age appropriate assent from the child
Exclusion criteria
Exclusion criteria: Patients with pre-existing oral mucosal disease unrelated to chemotherapy. Patients with known photosensitivity or current use of photosensitizing drugs.Patients with uncontrolled infection or active bleeding. Patients with any condition interfering with protocol compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the feasibility of photobiomodulation (PBM) therapy as an adjunct to standard supportive care in pediatric patients with chemotherapy-induced oral mucositis, defined by the proportion of patients who complete the planned PBM treatment.Timepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in National Cancer Institute Common Terminology Criteria for Adverse Events version 6 oral mucositis grade from baseline to Days 2 to 4, Day 7, and Day 10Timepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication.;Time to resolution of oral mucositis based on World Health Organization and National Cancer Institute Common Terminology Criteria for Adverse Events version 6Timepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication.;Change in pain scores measured using visual analog scaleTimepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication.;Analgesic consumption during the study periodTimepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication.;Requirement of nutritional support during the study periodTimepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication.;Occurrence of chemotherapy delays or interruptions during the study periodTimepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication.;Trends in absolute neutrophil count during the study periodTimepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analysis and publication.;Safety and tolerability of photobiomodulation therapy assessed by recording adverse eventsTimepoint: 0 to 6 Months: Patient screening, consenting, recruitment and collection of data 6-12 Months: Compilation of data, statistical analy | — |
Countries
India
Contacts
Public ContactDr Sandeep Gurav
Tata Memorial Hospital
Outcome results
None listed