Clinical trial NCT02052115: Behavioral Weight Loss and Exercise After Treatment (BEAT)
Official title: Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
exercise
weight loss
executive function
breast cancer survivor
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2014-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.

This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.


Eligibility criteria: Inclusion Criteria:

* Breast cancer diagnosis
* Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
* Completion of initial therapy 6 weeks prior to study initiation
* BMI of 27-45 kg/m\^2

Exclusion Criteria:

* Prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
* Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
* Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
* Age \<21 and \>70
* Presence of body metal
* Psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
* Evidence of metastatic disease
* Symptomatic heart disease (chest pain or equivalent with activity)
* Exercise limiting pulmonary disease or need for oxygen to exercise
* Individuals taking mood stabilizing medications including: Lithium, valproic acid, also called divalproex sodium (Depakote), carbamazepine (Tegretol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), ziprasidone (Geodon), clozapine (clorazil)
* Participants with an active neurologic disorder that affects the central nervous system, including seizures, and Parkinson's disease
* Weight loss of \>10 lbs in the previous 6 months
* Participation in \> 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity

Primary outcomes:
measure: Correlation of executive function and weight loss success
timeFrame: 12 months
Secondary outcomes:
measure: Correlation of cancer related symptoms and weight loss
timeFrame: 12 months
measure: Efficacy of a weight loss intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Vermont Cancer Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Kim Dittus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: