Impact of Ialuril Soft Gels in reducing urinary toxicity during radical hypofractionated radiotherapy in prostate cancer: a preliminary experience.
BACKGROUND
The aim of this study was to evaluate the impact of Ialuril Soft Gels in reducing acute genito-urinary (GU) toxicity in patients with prostate cancer treated with volumetric-modulated arc radiotherapy.


METHODS
Forty patients were prospectively recruited. A moderate hypofractionation in 28 fractions ("hypo-moderate") was prescribed in 20 patients, while an extreme hypofractionation ("hypo-extreme") in 5 fractions was prescribed in 20 patients. The International Prostate Symptom Score (IPSS) questionnaire was administered in all cases before and after radiotherapy (RT). GU toxicity was evaluated according to CTCAE v4.0. Patients of each group ("hypo-moderate" and "hypo-extreme") were randomized (1:1) to receive RT alone or RT combined with Ialuril Soft Gels.


RESULTS
In "hypo-moderate" patients treated with Ialuril Soft Gels the following GU toxicity was reported: G0 3, G1 6, G2 1, G3 0. In the arm treated without Ialuril Soft Gels: G0 0, G1 7, G2 2, G3 1. In "hypo-extreme" arm treated with Ialuril Soft Gels the following GU toxicity was recorded: G0 7, G1 2, G2 1, G3 in 0; while in the arm treated without Ialuril Soft Gels: G0 5, G1 2, G2 2, G3 1. IPSS was unchanged in "hypo-moderate" and "hypo-extreme" groups and patients treated with Ialuril Soft Gels, with a median value of 6 and 5 respectively. In patients treated without Ialuril Soft Gels an increased IPSS was reported in "hypo-moderate" and "hypo-extreme" from 6 to 8 and from 3.5 to 4.5, respectively. At statistical analysis (Fisher's exact text) Ialuril Soft Gels was associated with IPSS improvement (P=0.03).


CONCLUSIONS
Ialuril Soft Gels seems to have a beneficial role in reducing GU toxicity without worsening the IPSS.
Radiation Oncology Department, Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy - dott.filippoalongi@gmail.com.
Sergio
S
Fersino
Alba
A
Fiorentino
Niccolò
N
Giaj Levra
Rosario
R
Mazzola
Francesco
F
Ricchetti
Gioacchino
G
Di Paola
Stefano
S
Cavalleri
Filippo
F
Alongi
D000284:Administration, Oral; D000368:Aged; D002809:Chondroitin Sulfates / Q000008:administration & dosage*; D004338:Drug Combinations; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008297:Male; D060787:Neoplasm Grading; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000517:prevention & control*; D011880:Radiotherapy Planning, Computer-Assisted; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014566:Urogenital System / Q000528:radiation effects
D004338:Drug Combinations; C501944:chondroitin sulfate, sodium hyaluronate drug combination; D006820:Hyaluronic Acid; D002809:Chondroitin Sulfates