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

Primary Purpose

Oral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
low level laser therapy
placebo (laser low level energy nonfunctional)
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma focused on measuring Head and neck cancer, Low level laser therapy, Mucositis induced by radiochemotherpy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Institut de Cancerologie de l'Ouest Paul Papin
  • Centre Guillaume le Conquérant
  • Hôpital La Pitié Salpêtrière
  • Centre hospitalier universitaire La Milétrie
  • Centre Jean Godinot
  • Clinique Armoricaine de Radiologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

laser low-level energy functional

laser low-level energy nonfunctional

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

To evaluate the pain by a numerical analog, in its the nature and the dosage of analgesics consumed.
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)
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.
To assess the laser tolerance
To assess the quality of life using the QLQ-HN35 questionnaire.

Full Information

First Posted
January 16, 2013
Last Updated
January 4, 2019
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT01772706
Brief Title
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer
Acronym
LaserMucite
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2008 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a Phase III randomized, double-blind, multicenter study, with two groups of patients receiving radiotherapy and concomitant chemotherapy. The patients will be randomized as follows: Arm A = patients will receive a preventive and curative treatment by low-energy laser, and arm B = a control group treated with standard local treatments and a placebo laser (laser nonfunctional). Randomization will be balanced in a ratio 1: 1 and stratified by the investigator site. Assessments of mucositis, nutritional status, tolerance of the laser and pain will be performed throughout the treatment, once a week, by an investigator unaware of the patients treatment arm. The locoregional control will be evaluated every 3 months during the first year, then every 6 months up to 5 years. In case of progression, treatments undertaken and their results should be reported. Radiotherapy: All patients will be treated with conformal radiotherapy with or without IMRT. The dose should be adapted to the treatment indication (exclusive or postoperative) and the histological findings in case of tumoral resection. The radiotherapy will be prescribed in accordance with the recommendations of the ICRU 50 report. The dose delivered will always be 2 Gy per day 5 times a week. All beams will be treated in each session. A radiological audit will be conducted for each beam treated by photons in the first session and at least once a week. Chemotherapy: Several chemotherapies concomitant to radiotherapy are possible: a combination of 5-FU and Cisplatin a combination of 5-FU and Carboplatin Cisplatin alone Cetuximab alone Dental care: All patients (except edentulous) will be seen in odontostomatology consultation prior to the treatment for dental care if necessary or potential production of fluorinated gutters During the treatment, all patients will receive oral care The dosimetric study will concern the cross section, the frontal and sagittal planes through the axis of the lateral beams. Arm A : 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 grades superior or equal to 2 stomatitis injuries. The application is painless, athermal, odorless and completely silent. The patient will wear glasses for retinal protection. The operator will also wear glasses for his protection but allowing nevertheless the view of the beams and its limits. The tumor areas macroscopically invaded will be excluded from the areas application. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by a corresponding abacus : [t(s) = energy (J/cm2) x surface (cm2) / puissance (W)]. The overall duration will be a few minutes varying depending on the surface to be treated The usual dental care will be prescribed when required. Arm B : 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. All applications will be performed by one single operator by center. The results will be assessed once a week by another physician (or nurse specifically trained) in each center, unaware of whether the patients had laser sessions or not, in order to respect the "blinding". The assessment will be detailed on a specifique sheet, specifying the degree of mucositis (WHO), the level of pain, body weight , type of feeding , any analgesic treatment taken by the patient, quality of life specific questionnaire, and the possible end of treatment or therapeutic modifications (number of cycles of chemotherapy, dosage). The laser should be started as soon as a grade 2 mucositis (WHO) is observed and will be continued throughout the radio-chemotherapy until improvement of the mucositis (grade <2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Oral Mucositis
Keywords
Head and neck cancer, Low level laser therapy, Mucositis induced by radiochemotherpy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laser low-level energy functional
Arm Type
Experimental
Arm Description
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.
Arm Title
laser low-level energy nonfunctional
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
low level laser therapy
Intervention Type
Procedure
Intervention Name(s)
placebo (laser low level energy nonfunctional)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the pain by a numerical analog, in its the nature and the dosage of analgesics consumed.
Time Frame
7 weeks
Title
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
Title
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
Title
To assess the laser tolerance
Time Frame
7 weeks
Title
To assess the quality of life using the QLQ-HN35 questionnaire.
Time Frame
7 weeks
Other Pre-specified Outcome Measures:
Title
To evaluate the Locoregional control every 3 months for 1 year, then every 6 months up to 5 years.
Time Frame
5 years
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 75 years Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed PS > or = 2 Estimated life expectancy greater than 3 months in the absence of treatment 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 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. For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required. Exclusion Criteria: Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix Neoadjuvant chemotherapy Metastatic disease Previous treatment with ENT radiotherapy Severe hypersensitivity known to platinum based agent Any uncontrolled pathology (respiratory, cardiac, hepatic or renal) Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric JADAUD, MD
Organizational Affiliation
Institut de Cancerologie de l'Ouest - Paul Papin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de l'Ouest Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Guillaume le Conquérant
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Hôpital La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre hospitalier universitaire La Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Jean Godinot
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Clinique Armoricaine de Radiologie
City
Saint Brieuc
ZIP/Postal Code
22015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31118057
Citation
Legoute F, Bensadoun RJ, Seegers V, Pointreau Y, Caron D, Lang P, Prevost A, Martin L, Schick U, Morvant B, Capitain O, Calais G, Jadaud E. Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial. Radiat Oncol. 2019 May 22;14(1):83. doi: 10.1186/s13014-019-1292-2.
Results Reference
derived

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

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