Laser for Oral Mucositis in Pediatric Onco-hematology (LAMPO)

LAMPO: Multicenter Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Laser Therapy for Treatment of Oral Mucositis Induced by Chemotherapy in Children

Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side effects among which oral mucositis (OM) is one of the most debilitating. Modifications of CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor general conditions and debilitation. Moreover, the use of narcotic analgesics and total parenteral nutrition may be required, triggering not only a physical deficit but also an economic burden. Despite the frequency and impact of OM among children with cancer, there is no consensus on standard therapy for this condition. Previous studies demonstrated that high power laser therapy can help the maintenance of nutritional status in patients with OM and can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in reducing symptoms and in preventing the onset of OM in adult cancer patients but only one randomized controlled trial, with a limited number of children enrolled, supports its use in children for treatment of OM induced by chemotherapy.

This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.

The study involves 8 italian hospitals.

Study Overview

• Status: Completed
• Conditions: Stomatitis
• Intervention / Treatment: Device: Laser therapy; Device: Sham therapy

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • Policlinico Sant'Orsola Malpighi
  • Brescia, Italy
    • Spedali civili Ospedale dei Bambini
  • Cagliari, Italy
    • Ospedale Pediatrico Microcitemico "Antonio Cao"
  • Padova, Italy
    • Azienda Ospedaliera di Padova
  • Parma, Italy
    • Azienda Ospedaliero Universitaria di Parma
  • Pavia, Italy
    • Fondazione IRCCS, Policlinico San Matteo
  • Torino, Italy
    • A.O.U. Città della Salute e della Scienza di Torino
  • Trieste, Italy
    • IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 3-18 years
• Oral mucositis of grade 3 or 4 at enrollment (CTC - WHO scale)
• Antiblastic chemotherapy in the in the previous three weeks
• Willingness to undergo treatment for 4 consecutive days and to return for evaluation 7 and 11 days after enrollment.

Exclusion Criteria:

• Previous treatment with laser therapy for stomatitis
• Presence of dysplastic oral lesions
• Reduction of mouth opening (<1 cm)
• Localized head and/or neck radiation treatment in the previous 4 weeks
• Use of keratinocyte growth factor (KGF)
• Previous enrollment in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laser therapy; Children are allocated to receive Laser therapy	Device: Laser therapy; Treatment with K-Laser Cube3 during 4 consecutive days, with the following protocol: 660-970 nm wavelength, 3,2W mean power (6.4W pulsating at 50%), 3'51'' duration, 1-20000 Hz frequency, and 1 cm2 spot size. Laser application was performed all over the oral cavity.
SHAM_COMPARATOR: Sham therapy; Children are allocated to receive Sham therapy	Device: Sham therapy; Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the grade of oral mucositis	Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the World Health Organization (WHO) evaluation scale	7 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the grade of oral mucositis	Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale	3 days after enrollment
Reduction of the grade of oral mucositis	Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale	11 days after enrollment
Reduction of pain, age 4-7 years	Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)	3 days after enrollment
Reduction of pain, age 8-18 years	Reduction of self-reported pain recorded with a numeric rating scale	3 days after enrollment
Reduction of pain, age 4-7 years	Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)	7 days after enrollment
Reduction of pain, age 8-18 years	Reduction of self-reported pain recorded with a numeric rating scale	7 days after enrollment
Reduction of pain, age 4-7 years	Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)	11 days after enrollment
Reduction of pain, age 8-18 years	Reduction of self-reported pain recorded with a numeric rating scale	11 days after enrollment
Reduction of need for analgesics		at day 7
Adverse events		at day 11

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Giulio Andrea Zanazzo, MD, IRCCS Burlo Garofolo, Trieste; Study Chair: Matteo Biasotto, DDS, Azienda Ospedaliero Universitaria "Ospedali Riuniti", Trieste

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (ESTIMATE): May 4, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Treatment; Children; Chemotherapy; Laser; Stomatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: RC 33/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED