title: Hypericum perforatum and neem oil for the management of acute skin toxicity in head and neck cancer patients undergoing radiation or chemo-radiation: a single-arm prospective observational study.
abstract: BACKGROUND
  Radiation dermatitis is common in patients treated with combined radiotherapy and chemotherapy for head and neck malignancies. Its timely and adequate management is of uttermost importance for both oncological outcomes and global quality of life. We prospectively evaluated the role of hypericum perforatum and neem oil (Holoil®; RIMOS srl, Mirandola, Italy) in the treatment of acute skin toxicity for patients undergoing radiotherapy or chemo-radiotherapy for head and neck cancer.
  
  
  METHODS
  A consecutive series of 28 head and neck cancer patients submitted to radiotherapy (RT) was enrolled onto this mono-institutional single-arm prospective observational study. Patients undergoing both definitive or post-operative radiotherapy were allowed, either as exclusive modality or combined with (concomitant or induction) chemotherapy. We started Holoil treatment whenever bright erythema, moderate oedema or patchy moist desquamation were observed. Holoil® was used during all RT course and during follow up time, until acute skin toxicity recovery.
  
  
  RESULTS
  The maximum detected acute skin toxicity was Grade 1 in 7% of patients, Grade 2 in 68%, Grade 3 in 25%, while at the end of RT was Grade 0 in 3.5%, Grade 1 in 32%, Grade 2 in 61%, Grade 3 in 3.5%. For patients having G2 acute skin toxicity, it mainly started at weeks 4-5; for those having G3, it began during weeks 5-6. Median times spent with G2 or G3 toxicity were 17.5 and 11 days. Patients having G2 acute skin toxicity had a dermatitis worsening in 27% of case (median occurrence time: 7 days). G3 events were reconverted to a G2 profile in all patients (median time: 7 days). Those experiencing a G2 skin event were converted to a G1 score in 23% of cases (median time: 14 days). Time between maximum acute skin toxicity and complete skin recovery after RT was 27 days.
  
  
  CONCLUSIONS
  Holoil® proved to be a safe and active option in the management of acute skin toxicity in head and neck cancer patients submitted to RT or chemo-radiotherapy. A prophylactic effect in the prevention of moist desquamation may be hypothesized for hypericum and neem oil and need to be tested within a prospective controlled study.
authors.affiliation: Department of Oncology, Radiation Oncology, University of Turin School of Medicine, Via Genova 3, 10126, Turin, Italy. pierfrancesco.franco@unito.it.
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Franco
authors.affiliation: Department of Oncology, Radiation Oncology, University of Turin School of Medicine, Via Genova 3, 10126, Turin, Italy. ilenia.potenza@gmail.com.
authors.forename: Ilenia
authors.initials: I
authors.lastname: Potenza
authors.affiliation: Radiotherapy Department, AOU Città della Salute e della Scienza, Turin, Italy. moretto.francesco@hotmail.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Moretto
authors.affiliation: Department of Oncology, Radiation Oncology, University of Turin School of Medicine, Via Genova 3, 10126, Turin, Italy. mattia.segantin@gmail.com.
authors.forename: Mattia
authors.initials: M
authors.lastname: Segantin
authors.affiliation: Radiotherapy Department, AOU Città della Salute e della Scienza, Turin, Italy. pier4377@yahoo.it.
authors.forename: Mario
authors.initials: M
authors.lastname: Grosso
authors.affiliation: ENT Surgery Department, AOU Città della Salute e della Scienza, Turin, Italy. pfranco@ausl.vda.it.
authors.forename: Antonello
authors.initials: A
authors.lastname: Lombardo
authors.affiliation: Radiotherapy Department, AOU Città della Salute e della Scienza, Turin, Italy. uricardi@ausl.vda.it.
authors.forename: Daniela
authors.initials: D
authors.lastname: Taricco
authors.affiliation: Radiotherapy Department, AOU Città della Salute e della Scienza, Turin, Italy. pifranco@unito.it.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Vallario
authors.affiliation: Department of Oncology, Radiation Oncology, University of Turin School of Medicine, Via Genova 3, 10126, Turin, Italy. andreariccardo.filippi@unito.it.
authors.forename: Andrea Riccardo
authors.initials: AR
authors.lastname: Filippi
authors.affiliation: Radiotherapy Department, AOU Città della Salute e della Scienza, Turin, Italy. monicaramp100@gmail.com.
authors.forename: Monica
authors.initials: M
authors.lastname: Rampino
authors.affiliation: Department of Oncology, Radiation Oncology, University of Turin School of Medicine, Via Genova 3, 10126, Turin, Italy. umberto.ricardi@unito.it.
authors.forename: Umberto
authors.initials: U
authors.lastname: Ricardi
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects* / Q000379:methods; D005260:Female; D035264:Flowers / Q000737:chemistry; D005989:Glycerides / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D020902:Hypericum / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D011855:Radiodermatitis / Q000188:drug therapy*; D011878:Radiotherapy / Q000009:adverse effects; D013729:Terpenes / Q000627:therapeutic use*
chemical_list: D005989:Glycerides; D010936:Plant Extracts; D013729:Terpenes; C002443:neem oil