Carvalho, P.A., Jaguar, G.C., Pellizzon, A.C., Prado, J.D., Lopes, R.N., & Alves, F.A. (2011). Evaluation of low-level laser therapy in the prevention and treatment of radiation-induced mucositis: a double-blind randomized study in head and neck cancer patients. Oral Oncology, 47, 1176–1181.

DOI Link

Study Purpose

To determine the efficacy of low‐level laser treatment (LLLT) in the prevention and treatment of radioinduced oral mucositis in patients with oral and oropharynx cancer

Intervention Characteristics/Basic Study Process

Patients were randomized into two groups. Group 1 received 660 nm/15 mW/3.8 J/cm² spot size 4 mm² LLLT, and Group 2 received 660 nm/5 mW/1.3 J/cm² spot size 4 mm² LLLT, both beginning on the first day of radiation. In both groups, LLLT application was done daily for five consecutive days per week starting on the first day of radiation therapy. Prior to the study, all patients underwent oral care, including an oral examination, preventive dental treatment, instructions for oral care during radiation therapy, and prescription mouthwashes and fluoride treatment. Randomized sample selection was based on the eligibility criteria that each patient was diagnosed with cancer of the oral cavity or oropharynx and treated with radiation therapy.

Sample Characteristics

  • The study reported on a sample of 54 patients.
    • The mean patient age in group 1 was 57.1 (SD = 12.8) with a range of 22–94 years.
    • The mean patient age in group 2 was 58.1 (SD = 10.9) with a range of 35–79 years.
  • The sample was 66% male and 34% female.
  • Patients were included in the study if they received conventional, three-dimensional conformal radiotherapy or intensity-modulated radiation therapy with doses in facial fields equal to or greater than 4,000 cGy exclusively or associated with chemotherapy.

Setting

This was a single-site study conducted in an inpatient setting at Hospital A.C. Camargo, Sao Paulo Brazil.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a prospective, randomized, double-blind study.

Measurement Instruments/Methods

  • The National Cancer Institute (NCI) classification criteria for oral mucositis was used.
  • The World Health Organization (WHO) classification criteria for oral mucositis was used.
  • A visual analog scale was used for pain evaluation, with 0 equal to no pain and 10 equal to maximum pain.

Results

Group 1 had a delay in presentation with oral mucositis compared to Group 2 (13.5 days to 9.8 days, respectively). Group 2 presented with a higher grade of mucositis as compared to Group 1, and Group 2 reported higher overall pain scores.

Conclusions

This study reported a delay in development of mucositis, a decrease in severity of mucositis, and a decrease in pain scores with the group that received the higher dose of LLLT during treatment for oral or oropharynx cancer.

Limitations

  • The sample size was small, with fewer than 100 patients.
  • Other limitations of the study included the fact that the incidence of oral mucositis may be affected by the location of primary tumors in different sites of the oral cavity and oropharynx.
  • The study also did not take into account that some patients are reluctant to report pain symptoms, and no differences were found between the two groups in the reduction of analgesic administration.

Nursing Implications

Further studies are necessary to define dose, application time, and number of sessions needed for laser therapy in prevention and management of oral mucositis.