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).

Yohei Sasaki,Mina Honyashiki,Satoru Ikezawa,Akira Matsui,Takayuki Kinoshita,Mizuki Amano,Ryodai Yamamura,Yui Tomo,Ayako Nakashoji,Hisateru Tachimori,Naoki Yoshimura,Ryo Okubo,Yutaka J Matsuoka,Takuma Inagawa

doi:10.3390/mps4030046

Abstract

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).

Highlights

Among various types of psychological distress experienced by cancer survivors, the fear of cancer recurrence (FCR) is the most common and the most severe problem for which adequate support is often not available [1]
Completion of the protocol-specified interventions is defined as completion of least 4 of the 12 weeks of Bifidobacterium and perilla oil administration; these participants will be considered to have completed the protocol-specified interventions based on a meta-analysis of probiotic interventions for anxiety symptoms where the minimum treatment period in studies demonstrating efficacy was 4 weeks [45]
This study will be the first to examine the effects of a combination of probiotic and omega-3 fatty acids (Bifidobacterium and perilla oil) on psychiatric symptoms

Summary

Introduction

Among various types of psychological distress experienced by cancer survivors, the fear of cancer recurrence (FCR) is the most common and the most severe problem for which adequate support is often not available [1]. FCR can persist for years after finishing initial treatment, with more than half of cancer survivors experiencing moderately severe FCR and 7% experiencing extremely severe. With the exception of extremely severe FCR, for which pharmacological and/or psychiatric therapies are implemented in line with current treatment practices for anxiety disorder, FCR is generally considered to be an extension of normal psychology and was reported to be the most frequently endorsed unmet need at the end of initial treatment and 6 months post-treatment in a multicenter study conducted in the United Kingdom [2]. A Japanese study of 408 breast cancer survivors reported that 63% sought FCR-related care during treatment [3]. There is an ongoing need, for safe treatments for FCR that can be disseminated and that can offer cancer survivors a sense of security

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Conclusion