Anti-anxiety Biotics for Breast Cancer Survivors

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04784182
Study type	Interventional
Source	Auburn University
Contact
Status	Terminated
Phase	N/A
Start date	July 20, 2021
Completion date	May 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03080623` - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed	`NCT05527769` - Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Completed	`NCT06376578` - Exercise Interventions for Improving Health in Breast Cancer Survivors	N/A
Completed	`NCT03004534` - A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide	Early Phase 1
Recruiting	`NCT05020574` - Microbiome and Association With Implant Infections	Phase 2
Active, not recruiting	`NCT06277141` - The Vitality Mammography Messaging Study	N/A
Completed	`NCT03270111` - High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women	N/A
Completed	`NCT03555227` - USG PECS vs LIA for Breast Cancer Surgery	N/A
Active, not recruiting	`NCT03917082` - Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer	Phase 2
Recruiting	`NCT05561842` - Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Completed	`NCT04554056` - Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF	Phase 2/Phase 3
Not yet recruiting	`NCT06351332` - A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT)	Phase 1/Phase 2
Active, not recruiting	`NCT03127995` - Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence	N/A
Active, not recruiting	`NCT02237469` - Prone Breast Radiotherapy Treatment Planning Observational Study
Completed	`NCT01204125` - Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients	Phase 2
Recruiting	`NCT04565054` - Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC	Phase 3
Recruiting	`NCT03956641` - Evolution of the Physical Condition in Treated Cancer Patients	N/A
Recruiting	`NCT06087120` - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting	`NCT06058936` - Exercises Using Virtual Reality on Cancer Patients	N/A
Completed	`NCT03470935` - Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Anti-anxiety Biotics for Breast Cancer Survivors — ABBCS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms