Clinical trial NCT04784182: Anti-anxiety Biotics for Breast Cancer Survivors
Official title: Synbiotic Supplementation to Reduce Anxiety Symptoms in Female Breast Cancer Survivors and/or Their Female Relatives
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety Generalized
Breast Cancer Female
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-03-05
Enrollment: 3
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer survivors experience more rapid declines in health-related quality of life which include physical and psychological comorbidities, the latter of which may be subclinical and often overlooked by primary care providers. Recently, the gut-brain axis (GBA) has been identified as a therapeutic target to improve host health. The GBA is greatly influenced by the composition of the gut microbiome, as microbial metabolites directly influence the central nervous system. Thus, prebiotics, probiotics, and synbiotics (a combination of pre- and probiotics) have emerged as a possible approach to treating anxiety symptoms. Preclinical studies suggest efficacy of synbiotics, while pre- and probiotics have only been studied in isolation in humans.

This is a double-blind, placebo-controlled clinical trial in which female breast cancer survivors and/or their female relatives experiencing moderate to severe anxiety symptoms will be randomized to daily consumption of the synbiotic supplement or placebo. The previously validated Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptom severity at study screening and at each time point. The primary outcome of this study is feasibility, measured by accrual, adherence, retention, and adverse effects. Secondary outcomes relate to reduction of anxiety symptoms and other physiological changes. No study has investigated the mediating effects of gut microbiota and inflammatory markers on the ability of synbiotics to reduce anxiety symptoms. Thus, at each timepoint, phlebotomy will be conducted to determine serum levels of inflammatory cytokines and stool samples will be collected to determine alpha- and beta-diversity of the fecal microbiome as well as relative abundance of target genera. Hypothesis: this placebo-controlled study will be feasible and synbiotic treatment will result in a significant reduction in anxiety symptoms and inflammatory markers, which may be moderated by changes in the microbiome.


Eligibility criteria: Inclusion Criteria:

Female breast cancer survivors or female relatives of a breast cancer survivor who:

1. are 50 years of age or older
2. have completed primary treatment
3. currently experience clinical anxiety symptoms determined by the 7 item Generalized Anxiety Disorder screener (GAD-7; eligibility requires a total score of 5 or higher on the 21 point scale)
4. agree not to change dietary supplements throughout the course of the study
5. are willing to comply with daily supplement regimen
6. are able to speak and read English.

Exclusion Criteria:

1. use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics
2. changes in treatment for anxiety symptoms (i.e. initiation of Cognitive Behavior Therapy (CBT) within the last four weeks
3. current use (within 12 weeks) of anxiolytic medications.

Primary outcomes:
measure: Feasibility - Accrual
timeFrame: 6 months
measure: Feasibility - Retention
timeFrame: 6 weeks
measure: Feasibility - Adherence
timeFrame: 4 weeks
Secondary outcomes:
measure: Anxiety Symptoms
timeFrame: 4 weeks
measure: Serotonin
timeFrame: 4 weeks
measure: Inflammatory Marker - TNF-alpha
timeFrame: 4 weeks
measure: Inflammatory Marker - LBP
timeFrame: 4 weeks
measure: Inflammatory Marker - IL-6
timeFrame: 4 weeks
measure: Fecal Microbiome Composition
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Andrew D Frugé, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith KS, Greene MW, Babu JR, Fruge AD. Psychobiotics as treatment for anxiety, depression, and related symptoms: a systematic review. Nutr Neurosci. 2021 Dec;24(12):963-977. doi: 10.1080/1028415X.2019.1701220. Epub 2019 Dec 20.