Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., Maiya, A.G., & Vadhiraja, B.M. (2012). Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients: A triple blinded randomized controlled trial. Radiotherapy and Oncology, 104, 349–354.

DOI Link

Study Purpose

To examine the efficacy of low level laser therapy (LLLT) in patients with head and neck cancer receiving chemotherapy and radiation therapy (RT)

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive LLLT or sham treatment. Both groups received standard oral care and oral hygiene protocol, including frequent mouth washes with sodium bicarbonate. Patients in the LLLT group were treated with helium neon laser in 15–20 minute sessions, five sessions per week, at six anatomical sites in the oral cavity. Treatment was done daily prior to RT for 45 days. Patients, outcomes assessors, and statisticians were blinded to patient group assignment. Oral mucositis was assessed and graded daily.

Sample Characteristics

  • The study reported on 221 patients with a mean age of 55.4 years (SD = 11.4 years).
  • The sample was 85.5% male and 14.5% female.
  • All patients were newly diagnosed and receiving 100 m/m2 cisplatin on days 1, 22, and 43 and 66 Gy radiation in 33 fractions, five days per week.
  • All had stage 3 or 4 disease.  

Setting

This was a single-site, outpatient study conducted in India.

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

The study design was a randomized triple-blind sham-controlled randomized clinical trial.

Measurement Instruments/Methods

  • The European Organization for Research and Treatment of Cancer (EORTC) mucositis scoring system was used.
  • The need for supplemental analgesics and parenteral nutrition was recorded.
  • A visual analog scale was used to measure pain.

Results

  • Oral mucositis increased in both groups over time, but progressed more slowly in the laser group (p < 0.0001).
  • At the end of treatment, incidence of grade 3–4 mucositis was about three times lower in the laser group.
  • Duration of severe mucositis was less with the laser group.
  • The average number of RT fractions after which severe mucositis developed was higher in the laser group. 
  • Average pain scores were consistently lower in the laser group (p < 0.00001).
  • The need for total parenteral nutrition was lower in the laser group (p < 0.00001). 
  • Fewer patients in the laser group required any treatment delays.

Conclusions

Prophylactic LLLT in patients with head and neck cancer receiving concomitant radiation and chemotherapy was effective in reducing the incidence of severe oral mucositis.

Limitations

Without a longer-term follow up, long-term effects of LLT are not known.

Nursing Implications

Prophylactic use of LLLT was able to prevent and treat severe oral mucositis in this group of patients. This study adds to the growing body of evidence supporting the effectiveness of LLLT in patients with head and neck cancer receiving treatment, particularly in patients receiving chemotherapy with RT. Nurses can advocate for the use of LLLT in this patient population.