Perilla Oil and Bifidobacterium for Alleviating Fear of Cancer Recurrence in Breast Cancer Survivors: Study Protocol for a Three-Arm Phase II Randomized Controlled Study (POB Study)

The fear of cancer recurrence (FCR) is the most common and most severe unmet need among cancer survivors. Safe treatments for the FCR that are easily disseminated are greatly needed. Our primary aim is a preliminary evaluation of the efficacy and effect size of perilla oil, which is rich in omega-3 fatty acids, and Bifidobacterium, a probiotic, on FCR in breast cancer survivors after the completion of chemotherapy. This study has been planned as an exploratory clinical study (phase II) and will be conducted as a three-arm, 12-week parallel group, masked-rater randomized controlled trial. Fifteen participants will be randomized with 1:1:1 allocation to receive Bifidobacterium plus perilla oil, Bifidobacterium alone, or no intervention (control). Interventions will end within 12 weeks after the random allocation of each participant. The participants will be outpatients with invasive breast cancer aged 20 years or older whose chemotherapy was completed at least 6 months before registration; hormone therapy may be ongoing. The primary outcome will be severity of FCR at 12 weeks assessed by masked raters using the 4-item Concerns about Recurrence Scale concerning overall fear of recurrence. The study protocol for the current study is registered in the Japan Registry of Clinical Trials (jRCTs031200029).

Study on the Risk Assessment of Spontaneous Ignition and of Perilla Oil Cakes Associated Activation Energy

Perilla oil cakes are the residues of oil pressing processes, and used as fertilizers, feedstuff, food, etc. However, according to recent reports, perilla oil cakes often ignite spontaneously due to scorching heat, particularly in rice mills, general mills, and oil mills where large amounts of perilla oil cakes are stored. Thus, in this study, we attempted to elucidate the risk of spontaneous ignition of perilla oil cakes. For this purpose, thermogravimetry/differential thermal analysis (TG-DTA) was performed to identify thermal properties like weight reduction and heat generation, and spontaneous ignition was conducted for sample vessels of different thicknesses. The results showed that the ignition temperature of perilla oil cakes was 115 ℃ for the small (20 cm × 20 cm × 3 cm) vessel. The apparent activation energy associated with the critical ignition temperature was 60.74 kJ/mol. The ignition delay time and the time to reach maximum temperature were both found to increase with increasing vessel thickness. It was concluded that proper protection against heat must be in place because fire risk increases and spontaneous ignition can occur when large amounts of perilla oil cakes are accumulated.