Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Sep 10, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how exercise might affect the gut microbiome, which is the community of bacteria in our digestive system, in women who have survived breast cancer. The researchers want to understand if these changes in gut bacteria can help reduce feelings of fatigue, which is a common issue for many breast cancer survivors. The trial is currently looking for women aged 18 to 74 who have completed their breast cancer treatment at least a year ago and are experiencing some fatigue. Participants will need to get medical approval from their doctor and should be able to walk without help.

If you join the study, you can expect to engage in moderate exercise and the researchers will monitor any changes in your gut health and energy levels. It’s important to note that participants should not have any serious health conditions or other cancers, and they must avoid certain medications like antibiotics and probiotics during the study. This research aims to provide valuable insights into how exercise could potentially improve the well-being of breast cancer survivors by focusing on their physical and mental health.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
• • ≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
• • Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
• • English speaking,
• • Physician medical clearance for study participation,
• • Able to ambulate without assistance,
• • No antibiotics for the past 90 days,
• • Willing to avoid taking probiotics for the duration of the study
• • Peak VO2 \<30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).
• Exclusion criteria:
• • Metastatic or recurrent cancer
• • Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3)
• • Unstable angina
• • New York Heart Association class II, III, or IV congestive heart failure
• • Uncontrolled asthma
• • Interstitial lung disease
• • Current steroid use
• • Having been told by a physician to only do exercise prescribed by a physician
• • Dementia or organic brain syndrome
• • Schizophrenia or active psychosis
• • Connective tissue or rheumatologic disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
• • Anticipate elective surgery during the study period
• • Anticipate changes in usual medications during the study period
• • Plan to move residence out of the local area during the study period
• • Plan to travel out of the local area for \>1 week during study participation
• • Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
• • Currently pregnant or anticipate pregnancy during study participation
• • Live or work \>50 miles from study site or do not have transportation to study site
• • BMI \>50
• • Anticipate needing antibiotics during the study period