title: Skin toxicity from external beam radiation therapy in breast cancer patients: protective effects of Resveratrol, Lycopene, Vitamin C and anthocianin (Ixor®).
abstract: BACKGROUND
  This is an observational study and the aim is to evaluate the effect of dietary supplements based on Resveratrol, Lycopene, Vitamin C and Anthocyanins (Ixor®) in reducing skin toxicity due to external beam radiotherapy in patients affected by breast cancer.
  
  
  METHODS
  71 patients were enrolled and they were divided in two different groups: a control group (CG) of 41 patients treated with prophylactic topical therapy based on hyaluronic acid and topical steroid therapy in case of occurrence of radiodermatitis, and a Ixor-Group (IG) of 30 patients treated also with an oral therapy based on Resveratrol, Lycopene, Vitamin C and Anthocyanin (Ixor®) at a dose of 2 tablets/day, starting from 10 days before the radiation treatment until 10 days after the end of treatment. Skin toxicity has been related to PTV, to breast volume that received a radiation dose equal or lower than 107%, included between 107% and 110%, or greater than 110% of the prescribed dose. Moreover it's been studied the relationship between skin toxicity and the chemotherapy schedule used before treatment. We calculated in both groups the percentage of patients who had a skin toxicity of grade 2 or 3 (according to RTOG scale). Absolute risk reduction (ARR), relative risk (RR) and odds ratio (OR) have been calculated for each relationship.
  
  
  RESULTS
  Control Group (CG) patients with a PTV > 500 ml presented skin toxicity G2 + G3 in 30% of cases, versus 25% of Ixor-Group (IG) [OR 0.77]. In patients with a PTV < 500 ml G2 + G3 toxicity was 0% in the IG compared to 18% in CG (OR 0.23). When Dmax was less than or equal to 107% of the prescribed dose skin toxicity was G2 + G3 in 12.5% in CG, versus 0% in IG (OR 0.73), instead when Dmax was included between 107 and 110% of the prescribed dose, G2 + G3 skin toxicity was 35% in CG and 21% in IG (OR 0.50). In patients undergoing chemotherapy with anthracyclines and taxanes, G2 + G3 toxicity was 27% in CG, against 20% in IG (OR 0.68).
  
  
  CONCLUSIONS
  The protective effect of Resveratrol, Lycopene, Vitamin C and Anthocyanin (Ixor®) is more detected in patients with PTV < 500 ml, when Dmax reaches values lower or equal to 107%, but not exceeding 110% of the prescribed dose, and in patients undergoing adjuvant chemotherapy with anthracyclines and taxanes.
authors.affiliation: Dipartimento Diagnostica per Immagini e Radioterapia Seconda Università di Napoli-P.zza Luigi Miraglia-(80138) Napoli, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Di Franco
authors.forename: MariaGrazia
authors.initials: M
authors.lastname: Calvanese
authors.forename: Paola
authors.initials: P
authors.lastname: Murino
authors.forename: Roberto
authors.initials: R
authors.lastname: Manzo
authors.forename: Cesare
authors.initials: C
authors.lastname: Guida
authors.forename: Davide
authors.initials: D
authors.lastname: Di Gennaro
authors.forename: Caterina
authors.initials: C
authors.lastname: Anania
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Ravo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000872:Anthocyanins / Q000627:therapeutic use*; D000975:Antioxidants / Q000627:therapeutic use; D001205:Ascorbic Acid / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000150:complications / Q000532:radiotherapy*; D002338:Carotenoids / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077276:Lycopene; D008875:Middle Aged; D011379:Prognosis; D011837:Radiation-Protective Agents / Q000627:therapeutic use; D011855:Radiodermatitis / Q000209:etiology* / Q000517:prevention & control*; D020266:Radiotherapy, Conformal / Q000009:adverse effects*; D000077185:Resveratrol; D013267:Stilbenes / Q000627:therapeutic use*; D014815:Vitamins / Q000627:therapeutic use
chemical_list: D000872:Anthocyanins; D000975:Antioxidants; D011837:Radiation-Protective Agents; D013267:Stilbenes; D014815:Vitamins; D002338:Carotenoids; D001205:Ascorbic Acid; D000077185:Resveratrol; D000077276:Lycopene