NCT01876407

Brief Summary

The purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

June 10, 2013

Last Update Submit

February 4, 2016

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effectiveness of using low-intensity laser compared with placebo as preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy.

    24 months

Secondary Outcomes (5)

  • Evaluate the effectiveness of using low level laser compared with placebo in the prevention of onset of oral mucositis induced by treatment of head and neck QRT.

    24 months

  • Evaluate the effectiveness of the use of low laser intensity versus placebo in improving the healing of oral mucositis induced by treatment of head and neck QRT.

    24 months

  • Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.

    24 months

  • Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.

    24 months

  • Assess the intervention tolerance and side effects of it.

    24 months

Study Arms (2)

Low energy laser

EXPERIMENTAL

Administration of a low energy laser for oral mucositis.

Device: Low intensity laser for oral mucositis

Placebo

PLACEBO COMPARATOR
Device: Low intensity laser for oral mucositis switch off

Interventions

Low intensity laser for oral mucositisDEVICE
Low energy laser
Low intensity laser for oral mucositis switch offDEVICE

Low intensity laser for oral mucositis switch off

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with squamous cell carcinoma of the oral cavity.
  • Patients aged between 18 and 80 years.
  • Patients who are to receive one of the following treatment
  • Combined radiotherapy (conventional fractionation 70 Gy reaching the tumor and affected lymph nodes, and 50 Gy in the areas ganglion drainage) and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22 and 43 irradiation or cetuximab 400mg/m2 as a single dose pre-load radiotherapy and 250mg/m2 weekly for the same. Regardless of whether they have received previous surgical treatment.
  • Treatment with radiotherapy of 70 Gy in 35 daily sessions 2Gy/día consecutive.
  • Patients who voluntarily express their intention to participate by informed consent.

You may not qualify if:

  • Patients who denied informed consent.
  • Patients who have hypersensitivity or allergy to any of the components included in the study.
  • Patients diagnosed with HIV, and autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Daniel Torres Lagares

    Hospitales Universitarios Virgen del Rocío

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Torres Lagares

CONTACT

danieltl@us.es

María del Mar Benjumea Vargas

CONTACT

955 04 04 50gestionensayosclinicos.fps@juntadeandalucia.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

ES(1)