Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., Maiya, A.G., & Guddattu, V. (2015). Low level laser therapy against radiation induced oral mucositis in elderly head and neck cancer patients—A randomized placebo controlled trial. Journal of Photochemistry and Photobiology, B: Biology, 144C, 51–56. 

DOI Link

Study Purpose

To evaluate the effects of low level laser therapy (LLLT) for the prevention and treatment of radiation-induced oral mucositis (OM) in older adult patients with head and neck cancer (HNC)

Intervention Characteristics/Basic Study Process

All patients were treated with definitive radiation therapy (RT) with a dosage of 66 Gy given in 33 fractions daily, five days a week, for over 6.5 weeks. Just prior to radiation treatment, patients in both groups received the same amount of “laser treatment” sessions. The laser group was treated with laser therapy, and the placebo group received \"treatment\" with the laser probe turned off, although the beep signaled the end of treatment. Treatment was delivered to six anatomical sites bilaterally in the oral cavity: the ventral and lateral surface of the tongue, the labial mucosa, buccal mucosa, floor of the mouth, and palate. Doses were standardized.
 
The participants were assessed by an experienced radiation oncologist for OM, pain, and weight loss at the end of every week. Also, the need for morphine analgesics, enteral feeding, and RT break was recorded.

Sample Characteristics

  • N = 46  
  • AGE = Older than 60 years
  • MALES: 20 (90.9%) in the laser group and 19 (79.2%) in the placebo group, FEMALES: 2 (9.1%) in the laser group and 5 (20.8%) in the placebo group
  • CURRENT TREATMENT: Radiation 
  • KEY DISEASE CHARACTERISTICS: Primary HNC
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with lock jaw, any medical condition affecting healing mechanisms like diabetes, and who had prior radiation for HNC or were receiving any chemosensitizer were excluded.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Not specified

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

  • Randomized, placebo controlled trial

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group/European Organization for Research and Treatment for Cancer (RTOG/EORTC) scoring system for OM
  • Visual Analog Scale (VAS) for pain and weight loss
  • Weight changes
  • Data analysis was done using descriptive statistics.
  • ANOVA tests of repeated measures
  • Shapiro-Wilk test to test the normality of the data

Results

Laser group: Progression of OM toward higher grades was slower, less patients had severe oral pain, significantly less patients experienced OM (grade III and IV) (p = 0.016), less patients required total parenteral nutrition (TPN) support, the mean duration of severe oral pain was less (10 versus 16.5), the mean duration of TPN required was less, without statistical difference. Statistically significant difference existed in the duration of severe OM (p = 0.048) and severe oral pain (p = 0.028). Less patients required supplement opiod analgesics in the laser group (8.3%) than in the placebo group (35.7%).
 
Both groups experienced weight loss, but the laser group experienced less (2.58 kg versus 5.57 kg in placebo group) (p = 0.004). No significant differences arose among the groups in the first two weeks; however, week 3 onward showed a statistically significant difference, with greater loss in the placebo group (p < 0.05).
 
Radiation break due to severe OM was not required for any patient in the laser group; 14.3% of participants in the placebo group required a break.

Conclusions

LLLT seems to be an effective intervention in preventing OM in older adult patients with HNC. Larger, multisite trials are needed for validation.

Limitations

  • Small sample (< 100)
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%  
  • Patients all were said to have been kept on “standard oral care,” but that was never defined.
  • Lack of inter-rater reliability in using the scales, no mention of training or consistency in using the scales between the radiation oncologists
  • No mention of the calibration of the scales used to measure weight or mention of who weighed the patients

Nursing Implications

Nurses are vital in educating patients on good oral hygiene both before and during radiation treatments. Nurses see patients weekly, sometimes daily, and are essential to managing OM while patients undergo treatment, in combination with other methods such as LLLT investigated in this study. Reducing OM allows more patients to finish treatment.