This pilot study demonstrated that the combined use of CSNF gel and lotion delayed the occurrence of ARSR [greater than or equal to] G2 and may reduce the risk of moist desquamation of the irradiated skin by 50% [HR 2.33 (95% CI: 1.15-4.72)].
As the RTOG scale is comparable to the CTCAE 4.03 system, this finding highlights the fact that maintaining the integrity of the irradiated skin with either mechanical protection or pharmacological properties of an extract, such as CSNF, may prevent damage of the basal skin layer .
Although this result was not statistically significant, most likely due to the small number of patients included, it is another argument why the use of rescue treatment with Ialugen plus cream (sodium hyaluronate and silver sulfadiazine) was less frequent in the CSNF group (Figure 3).
Also, the CSNF gel and lotion were used as "open-label" drugs, and there was no "blinded" placebo control.
Abbreviations ARSR: Acute radiation-induced skin reaction CSNF: Camellia sinensis CTCAE: Common terminology criteria of adverse events G: Grade RT: Radiotherapy RTOG: Radiation Therapy Oncology Group SASRO: Scientific Association of Swiss Radiation Oncology UV: Ultra violet HR: Hazard ratio CI: Confidence interval SD: Standard deviation.
Novelpharm provided the study treatment (CSNF gel and lotion with NPE), participated in the study design, and supported data management and statistical analysis.
By simulation, the value [sigma] of two blends modified with CSnf and CSf was equal to 5.4 and 7.7, respectively (Table 2).
However, with the same CSR content, the DGEBA/26% CSnf blend still maintained a low value of elasticity caused by the absence of carboxy l-functionalized groups in the shell of the CSnf particles.
Figures 6a and b show the evolution of [b.sub.T]G'([omega][a.sub.T]) and [b.sub.T]G"([omega][a.sub.T]) master curves of two blends: DGEBA/13.6% CSf and DGEBA/13.6% CSnf as a function of reduced frequency [omega][a.sub.T] in log-log plots.
From results shown in Table 4, we noted that the values of relaxation times [[lambda].sub.M], [[lambda].sub.p], and [[lambda].sub.D] of the DGEBA/13.6% CSf blend were much higher than those of the DGEBA/13.6% CSnf blend.
In the case of the DGEBA/CSR blends, the G" model coincided with G" experimental, showing its slope equal to 1 for both CSf and CSnf. However, the G' master curve differed from the G' model at very low frequencies ([omega] [less than or equal to] [10.sup.-4] rad/s).
The yield viscosity occurred for the DGEBA/20% CSf blend demonstrated high interactions between the functionalized particles and the particles-matrix, whereas the DGEBA/26% CSnf blend still displayed Newtonian behavior.