Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies (BEAM)

Phase II Single Arm Study of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients

Chemotherapy induced oral mucositis is a common and debilitating complication in pediatric patients receiving chemotherapy for hematolymphoid malignancies. Oral mucositis can cause painful mouth ulcers, difficulty in eating and drinking, impaired nutrition, increased risk of infection, and significant discomfort. In severe cases, oral mucositis may lead to interruptions, delays, or dose modifications in chemotherapy, which can negatively affect cancer treatment outcomes and quality of life. Current management of chemotherapy induced oral mucositis is mainly supportive and includes maintenance of oral hygiene, bland mouth rinses, topical anesthetics, systemic analgesics, antimicrobial therapy when indicated, and nutritional support. However, these measures do not consistently promote healing of the oral mucosa or reduce the duration and severity of oral mucositis.

Photobiomodulation therapy is a non invasive treatment modality that uses low level red light to stimulate tissue repair, reduce inflammation, and improve pain control. Increasing evidence suggests that photobiomodulation therapy may reduce the severity and duration of chemotherapy induced oral mucositis and improve patient comfort. The treatment is painless, does not involve injections or additional medications, and has shown a favorable safety profile in previous studies. International supportive care guidelines have recommended photobiomodulation therapy in selected oncology settings for the management of oral mucositis.

The purpose of this Phase II single arm open label interventional study is to evaluate the feasibility and safety of photobiomodulation therapy as an adjunct to standard supportive care in pediatric patients with chemotherapy induced oral mucositis. The study will also explore preliminary clinical outcomes related to oral mucositis severity, pain control, nutritional support, and treatment interruptions.

This study will be conducted at Tata Memorial Hospital in Mumbai, India. Pediatric patients aged 3 to 14 years with hematolymphoid malignancies who are receiving chemotherapy and develop World Health Organization grade 2 or higher oral mucositis will be eligible for participation. Written informed consent will be obtained from parents or legal guardians along with age appropriate assent from the child before enrollment.

Participants enrolled in the study will continue to receive standard supportive care for oral mucositis as per institutional protocol. In addition, participants will receive photobiomodulation therapy administered using a handheld low level laser device operating at a wavelength of 660 nanometer. Photobiomodulation therapy will be administered once daily for four consecutive days by trained clinicians. The procedure is expected to take approximately 5 to 10 minutes depending on the extent of oral lesions.

Baseline assessments will include demographic details, diagnosis, chemotherapy information, oral mucositis grading, pain assessment, nutritional status, and routine blood investigation results including absolute neutrophil count where available. Oral mucositis severity will be assessed using World Health Organization oral mucositis grading and National Cancer Institute Common Terminology Criteria for Adverse Events version 6 grading systems. Pain will be assessed using the visual analog scale.

Participants will undergo daily assessments during the intervention period. Researchers will record oral mucositis severity, pain scores, analgesic requirement, nutritional support requirement, chemotherapy delays or interruptions, and adverse events. Absolute neutrophil count values obtained as part of routine oncologic care will also be documented. No additional blood investigations will be performed specifically for study purposes.

The primary outcome of the study is feasibility, defined as the proportion of participants who complete the planned photobiomodulation therapy sessions. Secondary outcomes include improvement in oral mucositis severity by Day 7, change in oral mucositis grade over predefined time points, time to resolution of oral mucositis, change in pain scores, analgesic consumption, nutritional support requirement, chemotherapy delays or interruptions, trends in absolute neutrophil count, and safety and tolerability of photobiomodulation therapy.

Participants will be followed until Day 10 after initiation of therapy for final clinical assessment and documentation of any late adverse events. The study aims to generate preliminary data regarding the feasibility and safety of photobiomodulation therapy in pediatric oncology patients with chemotherapy induced oral mucositis. If found to be feasible and well tolerated, photobiomodulation therapy may become a practical and cost effective adjunctive supportive care option for children receiving chemotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Mucositis Due to Chemotherapy; Hematolymphoid Malignancies
• Intervention / Treatment: Device: Photobiomodulation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandeep Gurav; Phone Number: 919769387712; Email: tmhdental@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients aged 3 to 14 years
• Diagnosed with hematolymphoid malignancies
• Currently receiving chemotherapy
• Presence of chemotherapy induced oral mucositis of World Health Organization grade 2 or higher at screening
• Written informed consent obtained from parent or legal guardian along with age appropriate assent from the participant

Exclusion Criteria:

• Pre existing oral mucosal disease unrelated to chemotherapy
• Known photosensitivity or use of photosensitising medications
• Uncontrolled infection or active bleeding
• Any medical or clinical condition interfering with protocol compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Photobiomodulation Therapy; Participants with chemotherapy induced oral mucositis will receive photobiomodulation therapy in addition to standard supportive care. Photobiomodulation therapy will be administered once daily for four consecutive days using a handheld low level laser device operating at 660 nanometer wavelength. Standard supportive care includes oral hygiene measures, bland mouth rinses, analgesics, antimicrobial therapy when indicated, and nutritional support as required.

Device: Photobiomodulation Therapy; Photobiomodulation therapy administered using low level laser therapy at 660 nanometer wavelength as an adjunct to standard supportive care for chemotherapy induced oral mucositis in pediatric patients with hematolymphoid malignancies. Treatment will be administered once daily for four consecutive days using a handheld laser device. Standard supportive care will be continued as per institutional protocol.; Other Names: Low Level Laser Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Photobiomodulation Therapy	Feasibility will be assessed by the proportion of participants completing the planned photobiomodulation therapy sessions as per protocol	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Oral Mucositis	Proportion of participants achieving at least one grade improvement in World Health Organization oral mucositis score from baseline.	Day 7
Change in Oral Mucositis Grade	Change in National Cancer Institute Common Terminology Criteria for Adverse Events version 6 oral mucositis grade from baseline at predefined study time points.	Up to Day 10
Time to Resolution of Oral Mucositis	Time required for complete resolution of oral mucositis based on World Health Organization and National Cancer Institute Common Terminology Criteria for Adverse Events version 6 grading systems.	Up to Day 10
Change in Pain Scores	Change in pain intensity measured using the visual analog scale during the study period	Up to Day 10
Analgesic Consumption	Assessment of analgesic requirement during the study period	Up to Day 10
Nutritional Support Requirement	Assessment of nutritional support requirement during the study period	Up to Day 10
Chemotherapy Delays or Interruptions	Assessment of chemotherapy delays or interruptions occurring during the study period	Up to Day 10
Trend in Absolute Neutrophil Count	Assessment of changes in absolute neutrophil count values obtained during routine clinical care	Up to Day 10
Safety and Tolerability of Photobiomodulation Therapy	Assessment of adverse events and tolerability associated with photobiomodulation therapy	Up to Day 10

Collaborators and Investigators

• Sponsor: Tata Memorial Hospital
• Investigators: Principal Investigator: Sandeep Gurav, Tata Memorial Hospital, Parel

Publications and helpful links

General Publications

• Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): April 23, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Supportive Care; Chemotherapy; Photobiomodulation; Pediatric Oncology; Oral Mucositis; Low Level Laser Therapy; Hematolymphoid Malignancies; mouth ulcers
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis; Oral Ulcer; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 5234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No