Laser for Oral Mucositis in Pediatric Onco-hematology

Stomatitis Clinical Trial

— LAMPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762019
• Other study ID #: RC 33/12
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2016
• Last updated: May 2, 2016
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomatitis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Reduction of pain, age 8-18 years	Reduction of self-reported pain recorded with a numeric rating scale	3 days after enrollment	No
Secondary	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	No
Secondary	Reduction of pain, age 8-18 years	Reduction of self-reported pain recorded with a numeric rating scale	7 days after enrollment	No
Secondary	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	No
Secondary	Reduction of pain, age 8-18 years	Reduction of self-reported pain recorded with a numeric rating scale	11 days after enrollment	No
Secondary	Reduction of need for analgesics		at day 7	No
Secondary	Adverse events		at day 11	Yes