Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients

Dana-Farber Cancer Institute

Status: Completed

Conditions: Low Level Light Therapy; Myeloablative Hematopoietic Cell Transplantation; Oropharyngeal Mucositis

Treatments: Device: Low Level Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02119897

13-611

Details and patient eligibility

About

Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.

Full description

This is an open label, single treatment arm clinical pilot study. The study is targeted to enroll twelve evaluable patients

OBJECTIVES:

Primary

• Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric patients undergoing HCT

Secondary

• Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral LLLT for prevention of OM
• Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric patients undergoing myeloablative HCT

Enrollment: 13 patients

Sex: All

Ages: 4 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at Boston Children's Hospital.
• 4 years of age to 25 years of age.
• WHO Oral Toxicity score of 0 at baseline evaluation (first day of conditioning).
• Ability to understand and the willingness to sign a written informed consent document (for patients under the age of 18 this applies to parent/guardian)
• Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.

Exclusion criteria

• Treatment with oral LLLT within 4 weeks of HCT.
• Participants may not be receiving any other agents intended for the prevention/management of mucositis (including palifermin and ice chips/cryotherapy).
• WHO ≥1 at baseline evaluation.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Low Level Light Therapy (LLLT)

Experimental group

Description:

* LLLT: The LLLT device will be positioned next to the face and neck for a total of 6 exposures: Right face, Midline face, Left face, Left neck, Midline neck, Right neck * Dose per anatomic site 50mW/cm2, 60 sec = 3.0J/cm2 * Route: Extraoral * Total Treatment Time (all sites): 6 min * Schedule: Participants will be treated daily (including weekends and holidays) beginning on the first day of HCT conditioning and continuing through day +20 or hospital discharge if prior to day +20. * Evaluation: Participants will undergo formal mucositis and toxicity assessments at baseline and daily from day -1 through day +20, with a final assessment on the last day of treatment.

Treatment:

Device: Low Level Light Therapy