NCT01772706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2008

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

11.3 years

First QC Date

January 16, 2013

Results QC Date

June 5, 2026

Last Update Submit

June 5, 2026

Conditions

Oral Squamous Cell CarcinomaSquamous Cell Carcinoma of OropharynxSquamous Cell Carcinoma of HypopharynxOral Mucositis

Keywords

Head and neck cancerLow level laser therapyMucositis induced by radiochemotherpy

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification

    The primary outcome is the number of patients with oral mucositis grade ≥2 as assessed by the World Health Organization (WHO) oral mucositis grading scale, reflecting functional impairment in oral intake. Oral mucositis is assessed weekly to evaluate the preventive and therapeutic efficacy of low-level laser therapy in patients undergoing concomitant radiotherapy and chemotherapy for stage III-IV head and neck squamous cell carcinoma.

    Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment

Secondary Outcomes (1)

  • Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)

    Assessment at Week 7, corresponding to the completion of concomitant chemoradiotherapy.

Study Arms (2)

laser low-level energy functional

EXPERIMENTAL

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.

laser low-level energy nonfunctional

PLACEBO COMPARATOR

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.

Interventions

low level laser therapyPROCEDURE
placebo (laser low level energy nonfunctional)PROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Institut de Cancerologie de l'Ouest Paul Papin

Angers, 49933, France

Location

Centre Guillaume le Conquérant

Le Havre, 76600, France

Location

Hôpital La Pitié Salpêtrière

Paris, 75013, France

Location

Centre hospitalier universitaire La Milétrie

Poitiers, 86021, France

Location

Centre Jean Godinot

Reims, 51100, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, 22015, France

Location

Related Publications (1)

  • 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.

    PMID: 31118057DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckStomatitisHead and Neck Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Results Point of Contact

Title
Marine TIGREAT
Organization
Institut de Cancérologie de l'Ouest
marine.tigreat@ico.unicancer.fr
+33240679878

Study Officials

  • Eric JADAUD, MD

    Institut de Cancerologie de l'Ouest - Paul Papin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 21, 2013

Study Start

October 30, 2008

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 1, 2026

Results First Posted

July 1, 2026

Record last verified: 2026-06

Locations

FR(6)