title: Photo-induced cytomorphologic changes in an advanced cancer phase I clinical trial.
abstract: OBJECTIVE
  The aim of this study was to investigate whether the application of an Infrared Pulsed Laser Device (IPLD) photo-induced significant cytomorphologic changes during the monitoring of advanced cancer patients participating in a phase I clinical trial.
  
  
  METHODS
  Patients were irradiated with an IPLD (904 nm pulsed at 3 MHz) under a one-dose, one-schedule, and one-procedure design. Total daily dose consisted of a Radiant Exposure of 4.5x10(5) J/m(2). Thirty-one tissue samples from eleven patients with progressive solid neoplastic diseases (TNM IV, UICC) were obtained at three intervals: Time 0 (15-90 days pre-treatment, n=11); Time I (2-5 months post-treatment; n=11); Time II (6-12 months post-treatment, n=09). Three blinded pathologists evaluated samples; scores were determined by consensus. Data were evaluated by using the Wilcoxon matched-pairs signed-rank test and Spearman rank correlation coefficient. The level of statistical significance was alpha=0.05.
  
  
  RESULTS
  Increased apoptosis (Time I, P<0.003; Time II, P<0.007), necrosis (Time I, NS; Time II, P<0.01), cytoplasmic vacuoles (Time I, P<0.03; Time II, P<0.02), and nuclear vacuoles (Time I, NS; Time II, P<0.01), reduced cell size (Time I, P<0.007; Time II, P<0.01) and intercellular adhesion (Time I, P<0.01; Time II, P<0.02) were present in neoplastic cells after IPLD treatment. No apparent changes were noted in non-neoplastic cells. The Spearman rank correlation coefficient between apoptosis, necrosis, nuclear vacuoles, cytoplasmatic vacuoles, intercellular adhesion, and cell size was positive and highly significant (P<0.006).
  
  
  CONCLUSIONS
  Although further research is necessary, our preliminary results support the novel possibility that the IPLD photo-induces chaotic dynamics that modulate complex physiologically reparative bioeffects.
authors.affiliation: Fundalas, Foundation for Interdisciplinary Research and Development, Caracas, Venezuela. fundalas@hotmail.com
authors.forename: Luis A
authors.initials: LA
authors.lastname: Santana-Blank
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Rodríguez-Santana
authors.forename: Fernando
authors.initials: F
authors.lastname: Vargas
authors.forename: Karin E
authors.initials: KE
authors.lastname: Santana-Rodríguez
mesh_terms: D000328:Adult; D000368:Aged; D017209:Apoptosis / Q000528:radiation effects; D001707:Biopsy, Needle; D002448:Cell Adhesion / Q000528:radiation effects; D002467:Cell Nucleus / Q000473:pathology / Q000528:radiation effects; D048429:Cell Size / Q000528:radiation effects; D005260:Female; D006801:Humans; D007259:Infrared Rays; D053685:Laser Therapy; D008297:Male; D008875:Middle Aged; D008938:Mitosis / Q000528:radiation effects; D009369:Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D014617:Vacuoles / Q000473:pathology / Q000528:radiation effects