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Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772706
Recruitment Status : Unknown
Verified January 2019 by Institut Cancerologie de l'Ouest.
Recruitment status was:  Active, not recruiting
First Posted : January 21, 2013
Last Update Posted : January 7, 2019
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief Summary:
The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma Squamous Cell Carcinoma of Oropharynx Squamous Cell Carcinoma of Hypopharynx Oral Mucositis Procedure: low level laser therapy Procedure: placebo (laser low level energy nonfunctional) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.
Actual Study Start Date : October 30, 2008
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: laser low-level energy functional
The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
Procedure: low level laser therapy
Placebo Comparator: laser low-level energy nonfunctional
The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
Procedure: placebo (laser low level energy nonfunctional)

Primary Outcome Measures :
  1. To evaluate the efficacy of preventive and curative low energy laser induced mucositis in patients receiving concomitant chemotherapy and radiotherapy for squamous cell carcinoma of the head and neck with stage III-IV [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. To evaluate the pain by a numerical analog, in its the nature and the dosage of analgesics consumed. [ Time Frame: 7 weeks ]
  2. To assess the nutritional status by body weight follow-up and the capability of swallowing various foods, and biologically the serum albumin, prealbumin, and optionally a measure of body fat (impedance, skinfolds) [ Time Frame: 7 weeks ]
  3. To assess the treatment compliance by the spread and discontinuation of radiation therapy, in duration (days) and the cause of discontinuations, the number of cycles of chemotherapy administered, and dose modifications or possible delays. [ Time Frame: 7 weeks ]
  4. To assess the laser tolerance [ Time Frame: 7 weeks ]
  5. To assess the quality of life using the QLQ-HN35 questionnaire. [ Time Frame: 7 weeks ]

Other Outcome Measures:
  1. To evaluate the Locoregional control every 3 months for 1 year, then every 6 months up to 5 years. [ Time Frame: 5 years ]
  2. To calculate the Disease-free survival from the date of randomization to the first event (recurrence or death) or up to 5 years. [ Time Frame: 5 years ]
  3. To document the Overall survival calculated from the date of randomization to death from any cause or up to 5 years. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age between 18 and 75 years
  2. Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed
  3. PS > or = 2
  4. Estimated life expectancy greater than 3 months in the absence of treatment
  5. Concomitant chemotherapy with one of the following choices not prohibited:

    • Cetuximab alone
    • 5-FU combined to Carboplatin or Cisplatin
    • Cisplatin alone Being defined as follows: serum creatinine < 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the Cockcroft method) in case of serum creatinine > 120 µmol/l
  6. Appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results:

    • Hemoglobin> 8g/dL
    • Neutrophils> 1500 x 109 / L
    • Platelets> 100 x 109 / l
    • Total bilirubin <1.5 times the upper limit of normal
    • ALT / AST and alkaline phosphatase <2.5 times the upper limit of normal.
  7. For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required.

Exclusion Criteria:

  1. Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix
  2. Neoadjuvant chemotherapy
  3. Metastatic disease
  4. Previous treatment with ENT radiotherapy
  5. Severe hypersensitivity known to platinum based agent
  6. Any uncontrolled pathology (respiratory, cardiac, hepatic or renal)
  7. Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772706

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Institut de Cancerologie de l'Ouest Paul Papin
Angers, France, 49933
Centre Guillaume le Conquérant
Le Havre, France, 76600
Hôpital La Pitié Salpêtrière
Paris, France, 75013
Centre hospitalier universitaire La Milétrie
Poitiers, France, 86021
Centre Jean Godinot
Reims, France, 51100
Clinique Armoricaine de Radiologie
Saint Brieuc, France, 22015
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
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Principal Investigator: Eric JADAUD, MD Institut de Cancerologie de l'Ouest - Paul Papin
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Institut Cancerologie de l'Ouest Identifier: NCT01772706    
Other Study ID Numbers: CPP400
2008-003681-26 ( EudraCT Number )
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Keywords provided by Institut Cancerologie de l'Ouest:
Head and neck cancer
Low level laser therapy
Mucositis induced by radiochemotherpy
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases