Phase II Study of the Effectiveness of the Germinated Wheat-derived Rigenase Plus Polyhexanide in the Prophylaxis for...

To assess the efficacy of the wheat extract rigenase plus the antiseptic polyhexanide spray in preventing and reducing the incidence of grade 2-3 acute radiation-induced skin toxicity (RIST) in patients undergoing adjuvant hypo-fractionated radiotherapy to the breast for cancer.

Three hundred and twenty-four patients participated in this study, enrolled in 15 centers in Southern Italy. Rigenase/polyhexanide was applied twice a day, starting on the first day and ending two weeks post-radiotherapy. Patients underwent weekly skin assessments throughout radiotherapy and at 2-4 weeks after treatment. Outcome measures were assessed using the Common Toxicity Criteria of the National Cancer Institute RIST criteria.

In most cases, RIST was observed after three weeks of radiotherapy. Grade 2 skin toxicity was recorded in 24% of patients, starting from week 2 with a peak at week 3. Grade 3 was observed starting from week 2 with a peak at week 3 where it was recorded in 4.5% of patients. The incidence of grade 2 and 3 progressively declined and disappeared by week 8. The median perceived benefit among patients and treating physicians differed significantly. All patients well tolerated treatment with rigenase/polyhexanide without meaningful side-effects. Twenty-one patients (0.06%) complained of light pruritus and two stopped rigenase/polyhexanide after 1 and 2 weeks.

Patients treated with adjuvant hypo-fractionated radiotherapy for breast cancer developed grade 2 RIST in slightly less than a quarter of cases with the use of rigenase/polyhexanide. No treatment delays or withdrawals were observed because of RIST. The tolerance was excellent.