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

This study is currently recruiting participants.
Verified January 2013 by Institut Cancerologie de l'Ouest
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT01772706
First received: January 16, 2013
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention 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)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Cancerologie de l'Ouest:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the pain by a numerical analog, in its the nature and the dosage of analgesics consumed. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the laser tolerance [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • To assess the quality of life using the QLQ-HN35 questionnaire. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To evaluate the Locoregional control every 3 months for 1 year, then every 6 months up to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772706

Contacts
Contact: Magali BALAVOINE 33 02 41 35 29 31 magali.balavoine@ico.unicancer.fr
Contact: François PEIN, MD francois.pein@ico.unicancer.fr

Locations
France
Institut de Cancerologie de l'Ouest Paul Papin Recruiting
Angers, France, 49933
Contact: Eric JADAUD, MD     33 02 41 35 29 31     eric.jadaud@ico.unicancer.fr    
Centre Guillaume le Conquérant Recruiting
Le Havre, France, 76600
Contact: Laurent MARTIN, MD     33 02 35 13 66 13     l.martin.oncorad-lehavre@orange.fr    
Hôpital La Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Jean AZERAD, MD, PhD     33 01 42 17 81 51     jean.azerad@psl.aphp.fr    
Centre hospitalier universitaire La Milétrie Recruiting
Poitiers, France, 86021
Contact: René-Jean BENSADOUN, MD, PhD     33 05 49 44 44 93     rene-jean.bensadoun@chu-poitiers.fr    
Centre Jean Godinot Recruiting
Reims, France, 51100
Contact: Alain PREVOST, MD     33 03 26 50 41 84     alain.prevost@reims.unicancer.fr    
Clinique Armoricaine de Radiologie Terminated
Saint Brieuc, France, 22015
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
Principal Investigator: Eric JADAUD, MD Institut de Cancerologie de l'Ouest - Paul Papin
  More Information

No publications provided

Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT01772706     History of Changes
Other Study ID Numbers: CPP400, 2008-003681-26
Study First Received: January 16, 2013
Last Updated: January 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Cancerologie de l'Ouest:
Head and neck cancer
Low level laser therapy
Mucositis induced by radiochemotherpy

Additional relevant MeSH terms:
Pharyngeal Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Stomatitis
Hypopharyngeal Neoplasms
Mucositis
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013