Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy: a double-blind randomised clinical trial
2003

Effects of Antibiotic Lozenges on Oral Mucositis in Head and Neck Cancer Patients

Sample size: 65 publication 10 minutes Evidence: moderate

Author Information

Author(s): Stokman M A, Spijkervet F K L, Burlage F R, Dijkstra P U, Manson W L, de Vries E G E, Roodenburg J L N

Primary Institution: University Hospital Groningen

Hypothesis

Does selective oral flora elimination reduce the development of irradiation-induced oral mucositis in head and neck cancer patients receiving radiotherapy?

Conclusion

The study found that antibiotic lozenges did not prevent severe mucositis but improved feeding quality and reduced weight loss.

Supporting Evidence

  • Patients receiving PTA lozenges had less weight loss compared to those on placebo.
  • 89% of patients in the PTA group developed pseudomembranes, similar to 94% in the placebo group.
  • 80% of PTA patients developed severe mucositis, compared to 90% in the placebo group.
  • Carriage of Candida species increased in the placebo group but decreased in the PTA group during the first two weeks.
  • Colonisation of aerobic Gram-negative bacilli was less in the PTA group during the radiation period.

Takeaway

This study tested if special lozenges could help people with mouth sores from cancer treatment, but they didn't really work for that, even though they helped with eating.

Methodology

A double-blind, placebo-controlled trial with random assignment of patients to receive either antibiotic lozenges or placebo during radiotherapy.

Potential Biases

Potential biases in patient selection and reporting due to the nature of the trial.

Limitations

The study only evaluated the first 5 weeks of radiation, which may not capture the full effects of mucositis development.

Participant Demographics

Patients with malignant tumors in the head and neck regions, aged around 54-56 years, with a mix of genders.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600824

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