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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02762019
Other study ID # RC 33/12
Secondary ID
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


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
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