Oral MucositisPhase 4NCT01876407
Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
A Phase 4 study testing Low intensity laser for oral mucositis and Low intensity laser for oral mucositis switch off in people with Oral Mucositis, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Low intensity laser for oral mucositis and Low intensity laser for oral mucositis switch off
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Daniel Torres Lagares contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Daniel Torres Lagares, danieltl@us.es
Daniel Torres Lagares
About this study
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.
- Conditions
- Oral Mucositis
- Being tested
- Low intensity laser for oral mucositis, Low intensity laser for oral mucositis switch off
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity laser for oral mucositisDevice
Low intensity laser for oral mucositis switch offDevice
Low intensity laser for oral mucositis switch off
| Study group | Role | What they receive |
|---|---|---|
| Low energy laser | Experimental | Administration of a low energy laser for oral mucositis. Receives: Device: Low intensity laser for oral mucositis |
| Placebo | Placebo comparator | Not described Receives: Device: Low intensity laser for oral mucositis switch off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 months
Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.
Measured: 24 months
Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.
Measured: 24 months
Assess the intervention tolerance and side effects of it.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Torres Lagares, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876407
- Sponsor's protocol ID
- FPS-LAS-2012-04
- Other IDs
- 001001006001
- Status last verified
- Feb 2016
- First submitted
- 10 Jun 2013
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01876407
- Acronym / sponsor ID
- FPS-LAS-2012-04
- Conditions
- Oral Mucositis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low energy laser | Experimental | Device: Low intensity laser for oral mucositisAdministration of a low energy laser for oral mucositis. |
| Placebo | Placebo comparator | Device: Low intensity laser for oral mucositis switch off |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity laser for oral mucositis | Device | Low energy laser |
| Low intensity laser for oral mucositis switch offLow intensity laser for oral mucositis switch off | Device | Placebo |
Primary outcome
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.
Time frame: 24 months
5 secondary outcomes
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.
Time frame: 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.
Time frame: 24 months
Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.
Time frame: 24 months
Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.
Time frame: 24 months
Assess the intervention tolerance and side effects of it.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
Related trials for Oral Mucositis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Torres Lagares contact
Daniel Torres Lagares principal investigator
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low intensity laser for oral mucositis and Low intensity laser for oral mucositis switch off in people with Oral Mucositis, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Torres Lagares (danieltl@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.