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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439724
Other study ID # INCABrazil
Secondary ID Protocol 17/2007
Status Completed
Phase Phase 3
First received September 20, 2011
Last updated March 7, 2014
Start date June 2007
Est. completion date December 2010

Study information

Verified date February 2013
Source Instituto Nacional de Cancer, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical 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. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date December 2010
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients using medication for treatment and or prevention of mucositis

- Patients incapable of treatment compliance or of performing the protocol of oral hygiene

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Instituto Nacional de Cancer Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Cancer, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 7 weeks No
Secondary 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. 7 weeks No
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