Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Metastatic Breast Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Wait List controlMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Aims/Objectives Aim 1. To examine the feasibility and acceptability of a 12 week cognitive-behavioral lifestyle intervention, assessing rates of study eligibility, accrual, adherence, and attrition. Aim 2. To examine the impact of a 12-week lifestyle intervention on body composition, the association...

Aims/Objectives Aim 1. To examine the feasibility and acceptability of a 12 week cognitive-behavioral lifestyle intervention, assessing rates of study eligibility, accrual, adherence, and attrition. Aim 2. To examine the impact of a 12-week lifestyle intervention on body composition, the associations with serum biomarkers of prognosis and survival, and patient reported outcomes. Hypothesis 1: Increases in LST with or without decreases in adipose tissue [measured by dual energy x-ray absorptiometry (DXA)] will be associated with improvements in the serum biomarkers of BC prognosis and survival [inflammatory markers (e.g., C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-?), interleukin-6 (IL-6)]; cytokines (e.g., leptin, adiponectin); insulin resistance (e.g., insulin, glucose)]. Hypothesis 2: Increases in LST with or without decreases in adipose tissue will be associated with improvements in symptom burden and quality of life. Exploratory Aim Aim 3. To explore the effect of a 12-week lifestyle intervention on mitochondrial function and its association with symptom burden.

Tracking Information

NCT #
NCT03824145
Collaborators
Loyola University Chicago
Investigators
Principal Investigator: Melinda Stolley, PhD Principal Investigator