Brest cancer breast cancer
Conditions
Interventions
Consuming one sachet of 3g perilla oil and two capsule of Bifidobacterium per day for 12 weeks
probiotics
Sponsors
Okubo Ryo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group differences in Concerns About Recurrence Scale at day85 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 D | — |
Contacts
Public ContactRyo Okubo
Department of Clinical Epidemiology, Translational Medical Center, National Center of Neurology and Psychiatry
Outcome results
None listed