@phdthesis{Schuster2019,
  author    = {Matthias Schuster},
  title     = {Clinical plasma medicine and head and neck cancer – Key points of clinical studies},
  journal    = {Klinische Plasmamedizin und Kopf-und Halstumore – Kernpunkte klinischer Studien},
  url       = {https://nbn-resolving.org/urn:nbn:de:gbv:9-opus-26402},
  pages     = {62},
  year      = {2019},
  abstract  = {Due to a variety of plasma sources in terms of type of discharge, energy yield, working gas or geometric factors, it is recommended to standardize the study protocol by choosing a plasma source and easy access to rugged tumor surfaces as demonstrated by the CAP-plasma-jet. The intention of the trial shall be to optimize the plasma jet for tumor site capability and operating room implementation. It makes sense to start clinical trials in plasma medicine with the treatment of head and neck squamous cell carcinoma patients of infected wounds and ulcerations. CAP is able to reduce contamination of cancer ulcerations and the typical fetid odor that often accompanies head and neck cancer patients. The intention of the trial shall be to evaluate the efficiency of decontamination in head and neck cancer ulcerations in terms of pathogenic species, amount of reduction and reliability. Standardize study protocol: Phase I, clinical explorative single-arm, randomized, open, multicenter Primary objective Reduction of microbial burden of cancer ulcerations by application of CAP Secondary objective: Reduction of tumor following local CAP application Inclusion: 20 Patients suffering from locally advanced oral cavity carcinoma with open tumor surfaces, treated with palliative intention and no more curative treatment options Exclusion: No wish for treatment, no compliance and understanding the protocol of the clinical study Efficacy: reduction of microbial burden; Documentation of visible changes by photography; Pathohistological and biochemical examination of specimen, taken from the tumor area and control areas Procedure: Plasma is applied for 1 minute per cm², spot area of 3 mm diameter distance between nozzle and tumor surface of 14 mm. 3 times/week with a break of 1 week followed by a repeated cycle for another week. Conclusion: The most important intention of the trial from the clinician’s point of view shall be to make CAP-treatment an effective and well-accepted addition to standard cancer therapy based upon EBM at least in palliative medicine.},
  language  = {en}
}