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
Legouté F, Bensadoun RJ, Seegers V, Pointreau Y, Caron D, Lang P, Prévost A, Martin L, Schick U, Morvant B, Capitain O, Calais G, Jadaud E
Radiation oncology (London, England) · 42 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Programme hospitalier de Recherche clinique
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2019-05-22 · Radiat Oncol · vol. 14 · número 1 · pág. 83
- Editorial
- BioMed Central
- Citado
- 112 citas · más que el 96% de estudios similares · 5.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 39 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Oral health in cancer treatment · Laser Applications in Dentistry and Medicine · Head and Neck Cancer Studies
- Palabras clave
- Medicine, Mucositis, Chemoradiotherapy, Head and neck cancer, Placebo, Surgery, Incidence (geometry), Clinical endpoint, Population, Low level laser therapy, Internal medicine, Randomized controlled trial, Radiation therapy, Laser therapy
- MeSH
- humans, carcinoma, squamous cell, head and neck neoplasms, stomatitis, prognosis, severity of illness index, quality of life, aged, middle aged, female, male, chemoradiotherapy, low-level light therapy
13 autores
- Florence Legouté🇫🇷 · autor de correspondenciaInstitut de Cancérologie de l'Ouest
- René‐Jean Bensadoun🇫🇷Centre de Haute Energie
- Valérie Seegers🇫🇷Institut de Cancérologie de l'Ouest
- Y. Pointreau🇫🇷Centre Jean Bernard; Clinique Victor Hugo
- Delphine Caron🇫🇷Institut de Cancérologie de l'Ouest
- Philippe Lang🇫🇷Assistance Publique – Hôpitaux de Paris
- Alain Prévost🇫🇷Institut Jean Godinot
- Laurent Martin🇫🇷Centre de Radiothérapie Bayard; Roche (France)
- Ulrike Schick🇫🇷Centre Hospitalier Régional Universitaire de Brest
- Benjamin Morvant🇫🇷Centre Hospitalier Universitaire d'Angers
- Olivier Capitain🇫🇷Institut de Cancérologie de l'Ouest
- G. Calais🇫🇷Institut de Cancérologie de l'Ouest
- Eric Jadaud🇫🇷Institut de Cancérologie de l'Ouest
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Low-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J/cm2.
Methods
This phase III trial was conducted in patients with oral cavity, or oro/hypopharyngeal cancers (stage III or IV). Patients were treated by lasertherapy on OM lesions grade ≥ 2 (4 J/cm2 or placebo), during chemoradiotherapy and until recovery. Severity of OM (incidence and duration of grades ≥3) was used as primary endpoint and blindly assessed.
Results
Among 97 randomised patients, 83 patients (85.6%) could be assessed finally (erroneous inclusions, chemoradiotherapy interruptions) and 32 patients had no lasertherapy because of unreachable OM lesions. Randomisation and population characteristics (sex ratio, age, chemoradiotherapy procedures, toxicities incidence) were still comparable between the two LLLT/PBMT groups. An acute OM (grade ≥ 3) was observed in 41 patients (49.4%): 23 patients (54.8%) of the active laser group versus 18 (43.9%) in the control group (modified intend to treat, p = 0.32). Median time before occurrence of OM ≥ grade 3 in half of the patients was 8 weeks in active laser group (vs. 9 weeks in control group). However, 95% of patients exhibited a very good tolerance of LLLT/PBMT.
Conclusions
This study assessed LLLT/PBMT according to the Multinational Association of Supportive care in Cancer recommendations but lacked power. LLLT/PBMT was well tolerated with a good safety profile, which promotes its use in clinical routine for severe OM treatment.
Trial registration
ClinicalTrials.gov Identifier: NCT01772706 .
Title
Laser Mucite ORL: Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite). Study Start Date: October 2008. Primary Completion Date: October 2016. Responsible Party: Institut de Cancérologie de l'Ouest - Paul Papin. Principal Investigator: Eric Jadaud, M.D., Institut de Cancérologie de l'Ouest - Paul Papin.
Funding
French Ministry of Health, French national funding scheme (PHRC 2008).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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