Perilla oil and Bifidobacterium for alleviating fear of cancer recurrence in breast cancer survivors

JRCT ID: jRCTs031200029

Registered date:08/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Brest cancer
• Date of first enrollment: 25/09/2020
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Consuming one sachet of 3g perilla oil and two capsule of Bifidobacterium per day for 12 weeks

Outcome(s)

• Primary Outcome: Group differences in Concerns About Recurrence Scale at day85

Secondary Outcome

Group differences in Hospital Anxiety and Depression Scale at day85
Group differences in Irritable bowel syndrome Severity Index at day85
Group differences in proportions of patients with lower level of Concerns About Recurrence Scale at day85
The correlations between changes in composition of gut microbiome and those in Concerns About Recurrence Scale from baseline to day85
The correlations between changes in composition of gut microbiome and those in Hospital Anxiety and Depression Scale from baseline to day85
The correlations between changes in composition of gut microbiome and those in Irritable bowel syndrome Severity Index from baseline to day85
The correlations between composition of gut microbiome at baseline and changes in Concerns About Recurrence Scale from baseline to day85
The correlations between composition of gut microbiome at baseline and changes in Hospital Anxiety and Depression Scale from baseline to day85
The correlations between composition of gut microbiome at baseline and changes in Irritable bowel syndrome Severity Index from baseline to day85
The correlations between composition of blood fatty acids at baseline and changes in Concerns About Recurrence Scale from baseline to day85
The correlations between composition of blood fatty acids at baseline and changes in Hospital Anxiety and Depression Scale from baseline to day85
The correlations between composition of blood fatty acids at baseline and changes in Irritable bowel syndrome Severity Index from baseline to day85
Group difference in patient background, intestinal flora composition, and fatty acid composition in blood at baseline between participants with reduced Concerns About Recurrence Scale scores (responder group) and participants without reduced Concerns About Recurrence Scale scores score (non-respond group)
Group difference in patient background, intestinal flora composition, and fatty acid composition in blood at baseline between participants with reduced Hospital Anxiety and Depression Scale scores (responder group) and participants without reduced Hospital Anxiety and Depression Scale score (non-respond group)
Group difference in patient background, intestinal flora composition, and fatty acid composition in blood at baseline between participants with reduced Irritable bowel syndrome Severity Index (responder group) and participants without reduced Irritable bowel syndrome Severity Index (non-respond group)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)patients aged 20 years or older
2)outpatients being treated at medical institutions conducting research
3)patients who had been diagnosed with invasive breast cancer
4)patients without cancer recurrence and over 6 months after chemotherapy
5)patients with moderate or sever fear of cancer recurrence assessed by Concerns About Recurrence Scale
6) patients whose diagnosis has been told by medical staffs as cancer

Exclude criteria

1)patients with cognitive impairment or disturbance of consciousness
2)patients unable to read and write Japanese
3)patients undergoing chemotherapy except for hormone therapy
4)patients who have severe idea of suicide or symptoms that require to urgent treatment
5)patients who were changed dose or type of their antidepressants/ anxiolytic in the last month
6)patients whose daily intake of food or supplements includes alpha-linolenic acid
7)patients whose daily intake of food or supplements includes Bifidobacterium
8)patients unsuitability to participate in this study as determined by the physician in charge of the study

Related Information

• Primary Sponsor: Okubo Ryo
• Source(s) of Monetary Support: Japan Society for the Promotion of Science: Grants-in-Aid for Scientific Research(19K20171),Japan Society for Lipid Nutrition: Ohta Oilmill Research Encouragement Award