Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., & Maiya, G.A. (2012). Low level helium neon laser therapy for chemoradiotherapy induced oral mucositis in oral cancer patients: A randomized controlled trial. Oral Oncology, 48, 893–897.

DOI Link

Study Purpose

To evaluate the therapeutic effects of a low level He-Ne laser on chemoradiation (CRT) -induced oral mucositis (OM), associated severe pain, and use of total parenteral nutrition (TPN) in patients with oral cancer

Intervention Characteristics/Basic Study Process

Block randomization was done using a computerized program taking primary oral cancer stage as a matching variable of 121 primary patients with oral cancer scheduled to undergo CRT (RT dosage = 66 Gray/33 fractions for five days per week and chemotherapy was three weeks cisplatin). Patients were randomized to either laser (n = 60) or placebo (n = 61). Both groups received standard oral care and hygiene. Patients and outcomes assessor were kept blinded for the laser intervention. OM, its associated pain, and TPN were assessed every week by a blinded assessor. Opioid analgesic use, weight loss, and any CRT breaks were recorded.   

Laser treatments used He-Ne 632.8 nm, power output of 24 mW, beam spot diameter of 0.6 mm, noncontact method (Technomed Electronics, Advanced Laser Therapy 1000, Chennai, India). This was applied to the anatomical sites in the oral cavity (buccal mucosa, lateral and ventral tongue, labial mucosa, floor of the mouth and palate), excluding cancer site daily just before radiation session for 6.5 weeks.

The placebo group received sham therapy (the probe was kept off, and there was only a beep sound) just before radiation for 6.5 weeks. 

Sample Characteristics

  • The study reported on 121 patients with cancer of the oral cavity.
  • The mean age of patients in the laser group was 51.71 years, and the mean age of patients in the placebo group was 52.60 years.
  • The sample was 91% male and 9% female.

Setting

This was a single-site study in a nonspecified setting in India.

Phase of Care and Clinical Applications

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability for end of life and palliative care.

Study Design

This was a prospective double blinded, randomized controlled trial.

Measurement Instruments/Methods

  • An experienced radiology oncologist who was blinded for the intervention group performed the assessment of the oral mucositis using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring system (grade 0–4).
  • The need for TPN was recorded at the end of every week.
  • Opioid analgesics use, weight less, CRT break during severe oral mucositis (grade > 2), and pain severity (using a visual analog scale [VAS]) of greater than 7 were recorded.

Results

During the last weeks of CRT, incidence of mucositis greater than grade 2 was less in the laser group than in the placebo group (p < 0.0001). The mean duration of severe grades of OM was less than in the placebo group.

At the third week of CRT, no statistical difference was found between groups for incidence of OM, severe pain, TPN, and weight loss.

The laser group had less need for opioid use (p < 0.001). None of the patients in the laser group required a break in CRT, but 9% of patients in the placebo group required a break in CRT.

OM progressed at a slower rate in the laser group than in the placebo group. Pain was less severe as rated by pain scores, and TPN was significantly less in the laser group than in the placebo group.

Conclusions

Low level He-Ne laser was found to decrease the incidence of CRT-induced, severe OM and its associated pain; opioid analgesic use; and TPN for patients with oral cancer.

Nursing Implications

Low level helium neon laser therapy for the reduction of chemotherapy-induced OM in patients with oral cancer appears to be helpful, but the therapy is limited because of the need for the laser and an experienced laser therapist. The laser therapy in this study included standard oral care and hygiene; therefore, laser therapy does not eliminate this need.

Long-term follow-up on the effects of laser on OM is recommended to understand the carryover effects of laser in these patients. Studies explaining the exact mechanisms of action of laser also are recommended.