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Squamous Cell Carcinoma of NasopharynxPhase 3NCT01439724

Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients

A Phase 3 study testing Low Level Laser Therapy- (DMC, São Paulo, Brazil) in people with Squamous Cell Carcinoma of Nasopharynx and Squamous Cell Carcinoma of Oropharynx, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Low Level Laser Therapy- (DMC, São Paulo, Brazil)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
1 siteBrazil
Study dates
Jun 2007to Dec 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and hypopharynx)
  • Candidates for surgery or treatment for organ preservation
  • Performance status (PS) of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
  • Indication for radiotherapy and concurrent platinum-based chemotherapy
  • Oral mucosa intact
  • Agree to follow the protocol of oral hygiene
  • Informed consent.

Who cannot join

  • Patients using medication for treatment and or prevention of mucositis
  • Patients incapable of treatment compliance or of performing the protocol of oral hygiene

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto Nacional de Cancer

    Rio de Janeiro, Rio de Janeiro, 20231-050

Other trials in Brazil

About this study

Official title: Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation

Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.

Read the detailed description

Assuming oral mucositis grade 3 for placebo 0.4 (P0); laser group 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 laser group and 47 placebo patients bearer of head and neck squamous cell carcinomas of nasopharynx, oropharynx and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. chemoradiotherapy consisted of conventional radiotherapy 70.2 Gray (Gy) (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 weeks. The primary end point was the incidence of grade 3-4 oral mucositis. The Low-level laser therapy used daily, was a diode indium phosphide, gallium and aluminum (InGaAlP), 660nm-100 milliwatts (mW)-4 Joules (J)/cm²(DMC, São Carlos, São Paulo, Brazil). Oral mucositis evaluation was done by WHO and Oral Mucositis Assessment Scale (OMAS) scale.

Being tested
Low Level Laser Therapy- (DMC, São Paulo, Brazil), Placebo (DMC, São Paulo, Brazil)
Keywords
Oral mucositis, Low Level Laser Therapy, Head and neck cancer
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Stomatitis, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Level Laser Therapy- (DMC, São Paulo, Brazil)Device

    Also called Low Power Laser Therapy, Low Energy Laser Therapy

    Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.

  • Placebo (DMC, São Paulo, Brazil)Device

    Also called Low power laser therapy, Low energy laser therapy

    The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

Study groups in NCT01439724
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPatients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Receives: Device: Placebo (DMC, São Paulo, Brazil)
Low Level Laser TherapyExperimentalThe investigators used a Low Level Laser Therapy, diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
Receives: Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and / or Severity of Oral Mucositis

    The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.

    Measured: 7 weeks

Secondary outcomes (1)

  1. Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.

    Oral mucositis survival free, pain, opioid treatment, hospitalization, treatment interruption, treatment delay, patient weight loss, nasogastric tube or of a gastrostomy.The oral cavities of all patients were evaluated, from the first day to the last day of treatment.

    Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2011 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2008
  4. Study completionDec 2010

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01439724
Sponsor's protocol ID
INCABrazil
Other IDs
Protocol 17/2007
Status last verified
Feb 2013
First submitted
20 Sep 2011
Last updated
11 Apr 2014
Data monitoring committee
Yes

Publications

  • Antunes HS, Schluckebier LF, Herchenhorn D, Small IA, Araujo CM, Viegas CM, Rampini MP, Ferreira EM, Dias FL, Teich V, Teich N, Ferreira CG. Cost-effectiveness of low-level laser therapy (LLLT) in head and neck cancer patients receiving concurrent chemoradiation. Oral Oncol. 2016 Jan;52:85-90. doi: 10.1016/j.oraloncology.2015.10.022. Epub 2015 Nov 11.

    PubMed 26559740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low Level Laser Therapy- (DMC, São Paulo, Brazil) in people with Squamous Cell Carcinoma of Nasopharynx and Squamous Cell Carcinoma of Oropharynx, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.

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 8 inclusion and 2 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: finished, as of the sponsor's last update on 11 Apr 2014. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and / or Severity of Oral Mucositis (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01439724, which also lists 1 linked publication.

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 11 Apr 2014.

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