Antunes, H.S., Herchenhorn, D., Small, I.A., Araújo, C.M., Viégas, C.M.P., Cabral, E., . . . & Ferreira, C.G. (2013). Phase III trial of low-level laser therapy to prevent oral mucositis in head and neck cancer patients treated with concurrent chemoradiation. Radiotherapy and Oncology, 109(2), 297–302.

DOI Link

Study Purpose

To assess the efficacy of preventive low-laser therapy to reduce grade 3 and 4 oral mucositis (OM) in patients receiving chemoradiation

Intervention Characteristics/Basic Study Process

Both groups received cisplat 100 mg/m2 for three cycles every three weeks, radiation 70.2 Gy (1.8 Gy per day five times per week), and the same oral hygiene. The intervention group received low-level laser therapy five times per week before every fraction of radiation. The energy and energy density were the same for each patient. A dentist applied the laser tip to the mucosa of the lips, the right and left buccal mucosa, the left and right lateral tongue border, the buccal floor, and the ventral tongue. The placebo group had the laser tip touched to the same sites, but there was no laser light.

Sample Characteristics

  • N = 94   
  • AGE: 10–18 years
  • MALES: Laser group: 89%, placebo: 85%; FEMALES: Laser group: 11%, placebo: 15%
  • KEY DISEASE CHARACTERISTICS: Patients with squamous cell carcinoma of the head and neck
  • OTHER KEY SAMPLE CHARACTERISTICS: Had to be ineligible for surgery, be able to tolerate chemo/radiation, have Eastern Cooperative Oncology Group status of 0 or 1, have had an intact oral mucosa at the start of the study

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient   
  • LOCATION: Brazilian National Cancer Institute in Rio de Janeiro

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Prospective, randomized, double-blind, placebo-controlled, phase III trial

Measurement Instruments/Methods

  • World Health Organization Oral Mucositis Scale
  • Oral Mucositis Assessment Scale
  • Visual analog scale for pain
  • The European Organization for Research and Treatment of Cancer QLQ-C30

Results

A significant decrease was seen in the rate of grades 3 and 4 OM in the treatment group. Relative risk ratio (6.4% with laser versus 40.5% control) 0.158 (CI 95%). The treatment group reported better physical, emotional, fatigue, and pain scores and had less pain, fewer problems swallowing, and less trouble with social eating.

Conclusions

Low-level laser light therapy is effective in reducing grades 3 and 4 OM in patients with squamous cell carcinoma of the head and neck undergoing concurrent chemotherapy and radiation.

Limitations

  • Small sample (< 100)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs

Nursing Implications

Nurses who work in facilities with access to low-level laser light therapy should advocate for the use of it for their patients with head and neck cancer undergoing radiation and chemotherapy. There may be a role for nurses in learning to administer low-level laser light therapy.