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Completed

NCT Number: NCT02762019

Laser for Oral Mucositis in Pediatric Onco-hematology

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.

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Key information

Conditions

Stomatitis Mouth Diseases Stomatognathic Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Policlinico Sant'Orsola Malpighi, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham Therapy

Device

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

Primary outcomes

  1. Reduction of the grade of oral mucositis

    Time frame: 7 days after enrollment

    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

Secondary outcomes

  1. Reduction of the grade of oral mucositis

    Time frame: 3 days after enrollment

    Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale

  2. Reduction of the grade of oral mucositis

    Time frame: 11 days after enrollment

    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. Reduction of pain, age 4-7 years

    Time frame: 3 days after enrollment

    Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)

  4. Reduction of pain, age 8-18 years

    Time frame: 3 days after enrollment

    Reduction of self-reported pain recorded with a numeric rating scale

  5. Reduction of pain, age 4-7 years

    Time frame: 7 days after enrollment

    Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)

  6. Reduction of pain, age 8-18 years

    Time frame: 7 days after enrollment

    Reduction of self-reported pain recorded with a numeric rating scale

  7. Reduction of pain, age 4-7 years

    Time frame: 11 days after enrollment

    Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)

  8. Reduction of pain, age 8-18 years

    Time frame: 11 days after enrollment

    Reduction of self-reported pain recorded with a numeric rating scale

  9. Reduction of need for analgesics

    Time frame: at day 7

  10. Adverse events

    Time frame: at day 11

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study 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

Acronym: LAMPO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 4, 2016
Registry last updated
May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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