Breast Cancer Female Clinical Trial
Official title:
Synbiotic Supplementation to Reduce Anxiety Symptoms in Female Breast Cancer Survivors and/or Their Female Relatives
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.
n/a
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 | |
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 | |
Not yet recruiting |
NCT06412133 -
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
|
N/A | |
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
|