Laser for Oral Mucositis in Pediatric Onco-hematology

NCT02762019 | Completed Phase 3

• 1 other identifier: RC 33/12
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Stomatitis

Keywords

Stomatitis; Laser; Children; Chemotherapy; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Reduction of the grade of oral mucositis

  3 days after enrollment

• Reduction of the grade of oral mucositis

  11 days after enrollment

• Reduction of pain, age 4-7 years

  3 days after enrollment

• Reduction of pain, age 8-18 years

  3 days after enrollment

• Reduction of pain, age 4-7 years

  7 days after enrollment

Study Arms (2)

Laser therapy

EXPERIMENTAL

Children are allocated to receive Laser therapy

Device: Laser therapy

Sham therapy

SHAM COMPARATOR

Children are allocated to receive Sham therapy

Device: Sham therapy

Interventions

Laser therapy DEVICE

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.

Laser therapy

Sham therapy DEVICE

Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.

Sham therapy

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (8)

Policlinico Sant'Orsola Malpighi

Bologna, Italy

Location

Spedali civili Ospedale dei Bambini

Brescia, Italy

Location

Ospedale Pediatrico Microcitemico "Antonio Cao"

Cagliari, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Azienda Ospedaliero universitaria di Parma

Parma, Italy

Location

Fondazione IRCCS, Policlinico San Matteo

Pavia, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy

Location

IRCCS Burlo Garofolo

Trieste, Italy

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Giulio Andrea Zanazzo, MD

  IRCCS Burlo Garofolo, Trieste

  STUDY CHAIR

• Matteo Biasotto, DDS

  Azienda Ospedaliero Universitaria "Ospedali Riuniti", Trieste

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 4, 2016
• Study Start: September 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 4, 2016

Record last verified: 2016-05

Locations

IT (8)