論文

査読有り 責任著者 本文へのリンクあり 国際誌
2021年7月6日

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).

Methods and protocols
ダウンロード
回数 : 72
  • Yohei Sasaki
  • Mina Honyashiki
  • Takayuki Kinoshita
  • Akira Matsui
  • Ayako Nakashoji
  • Takuma Inagawa
  • Satoru Ikezawa
  • Naoki Yoshimura
  • Ryodai Yamamura
  • Mizuki Amano
  • Yui Tomo
  • Hisateru Tachimori
  • Yutaka J Matsuoka
  • Ryo Okubo
  • 全て表示

4
3
開始ページ
46
終了ページ
46
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.3390/mps4030046
出版者・発行元
MDPI AG

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).

リンク情報
DOI
https://doi.org/10.3390/mps4030046
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/34287371
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293445
共同研究・競争的資金等の研究課題
乳がんサバイバーの行動変容と患者ケアの効果予測
共同研究・競争的資金等の研究課題
膵がんの発症・病期進行・治療応答性・生活の質と相関する細菌叢バイオ マーカーおよび新規治療法の創出
共同研究・競争的資金等の研究課題
がん再発不安に対するオメガ3系脂肪酸・プロバイオティクスの有効性の検討
共同研究・競争的資金等の研究課題
がん再発不安に対するアルファリノレン酸・プロバイオティクスの有効性の検討
URL
https://www.mdpi.com/2409-9279/4/3/46/pdf
ID情報
  • DOI : 10.3390/mps4030046
  • eISSN : 2409-9279
  • PubMed ID : 34287371
  • PubMed Central 記事ID : PMC8293445

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