Combined Modality Exercise and Appetite in Breast Cancer Survivors

Study Overview
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Brief Summary
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The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS).

Official Title
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Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)

Conditions
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Breast Cancer Female, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Combined aerobic and resistance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female sex Age: 18 - 45 years Body mass index [BMI]: 25 - 35 kg/m2 Pre-menopausal before cancer diagnosis and treatment <1 hour/week of planned physical activity by self-report in the previous 12 months Diagnosis of primary stage I - III estrogen receptor/progesterone receptor-positive (ER/PR+) breast cancer, according to institutional standards. All chemotherapy, radiation, and surgery completed at least two weeks (14 days), but less than 6 months prior to registration Exclusion Criteria: Self-reported diabetes mellitus, untreated/uncontrolled thyroid disease, history of cardiovascular disease or symptoms suggestive of cardiovascular disease (chest pain, shortness of breath at rest or with mild exertion, syncope), cancer diagnosis in the last 5 years before breast cancer (any site, excluding skin cancer), or any other medical condition affecting weight or energy metabolism. Uncontrolled hypertension defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition becomes controlled they will be allowed to be re-evaluated for inclusion in the current trial. Unable to exercise due to cardiac, pulmonary, neurological, orthopedic reasons. Currently smoking and/or nicotine use. Treatment with medications known to significantly affect appetite, weight, energy intake or expenditure in the last 3 months (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants). Corticosteroid use within the last two weeks History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons Currently pregnant, lactating or less than 6 months post-partum. Score of ≥ 2 on the CAGE (cut-annoyed-guilty-eye opener) questionnaire adapted to include drug use55 Score of > 20 on the Eating Attitude Test - 26 (EATS-26), indicative of disordered eating. Participants with a score >20 on the EATS-26 will be referred to their primary care physician for further evaluation. Significant food intolerances/allergies that cannot be accommodated by the University of Colorado Hospital Clinical Translational Research Center Metabolic Kitchen. Currently participating in any formal weight loss or physical activity programs or clinical trials for weight loss. Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician). Unable or unwilling to undergo study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined aerobic and resistance exercise<br>12 weeks of supervised resistance exercise and unsupervised aerobic exercise. | Behavioral: Combined aerobic and resistance exercise<br>* The 12-week intervention will build upon an ongoing resistance exercise program for cancer patients and survivors at the University of Colorado's Anschutz Health and Wellness Center. Resistance exercise will be led by certified cancer exercise specialists who provide individualized exercise programs to cancer patients and survivors. Exercise sessions are progressive, target all major muscle groups, are 50 minutes in duration, and completed 2x/week. The intervention will also include 3 self-directed moderate-intensity aerobic exercise sessions/week, building to 50 minutes at 60% heart rate maximum (determined at baseline). Target exercise will be achieved by a gradual progression of exercise duration over the first four weeks of the program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment and enrollment feasibility | Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study | Through study completion, up to two years | 
| Subjective exercise adherence | Participants will be asked to rate on a 1-10 Likert scale: 1) how adherent they were to the prescribed exercise over the past week, 2) how difficult it was to adhere to the prescribed exercise over the past week, and 3) how likely they feel they can adhere to the prescribed exercise for the next month. | Changes across weeks 4, 8, and 12 | 
| Exercise self efficacy | Self Efficacy for Exercise Scale; 9 items; score range: 0-9, with higher scores indicating higher exercise self-efficacy | Changes across weeks 4, 8, and 12 | 
| Exercise enjoyment | Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment | Changes across weeks 4, 8, and 12 | 
| Intervention acceptability | Subjective ability to adhere to combined AEx/REx | 12 weeks | 
| Intervention acceptability | Barriers to completing AEx/REx | 12 weeks | 
| Intervention acceptability | Open-ended opinions on the structure and content of the exercise training sessions | 12 weeks | 
| Intervention acceptability | Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention | 12 weeks | 
| Objective exercise adherence | Adherence to additional study-specific AEx will be tracked through heart rate monitor data, logs of attendance, and participant diaries and compared to the REx-only intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ghrelin | Fasting ghrelin, ghrelin area under the curve in response to a control meal | Baseline, 12 weeks | 
| Changes in peptide-YY (PYY) | Fasting PYY, PYY area under the curve in response to a control meal | Baseline, 12 weeks | 
| Changes in subjective appetite ratings | Changes in hunger, satiety, and prospective food consumption via visual analog scales | Baseline, 12 weeks | 
| Changes in ad libitum energy intake | Energy intake from buffet-style meal | Baseline, 12 weeks | 
| Changes in physical activity | Step count measured by accelerometers | Baseline, 12 weeks | 
| Changes in sedentary behavior | Time in sedentary activities measured by accelerometers | Baseline, 12 weeks |