Combined Modality Exercise and Appetite in Breast Cancer Survivors
- Conditions
- Breast Cancer FemaleOverweight and Obesity
- Interventions
- Behavioral: Combined aerobic and resistance exercise
- Registration Number
- NCT04576247
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combined aerobic and resistance exercise Combined aerobic and resistance exercise 12 weeks of supervised resistance exercise and unsupervised aerobic exercise.
- Primary Outcome Measures
Name Time Method Recruitment and enrollment feasibility Through study completion, up to two years Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study
Subjective exercise adherence Changes across weeks 4, 8, and 12 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.
Exercise self efficacy Changes across weeks 4, 8, and 12 Self Efficacy for Exercise Scale; 9 items; score range: 0-9, with higher scores indicating higher exercise self-efficacy
Exercise enjoyment Changes across weeks 4, 8, and 12 Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment
Intervention acceptability 12 weeks Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention
Objective exercise adherence 12 weeks 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
- Secondary Outcome Measures
Name Time Method Changes in peptide-YY (PYY) Baseline, 12 weeks Fasting PYY, PYY area under the curve in response to a control meal
Changes in ghrelin Baseline, 12 weeks Fasting ghrelin, ghrelin area under the curve in response to a control meal
Changes in physical activity Baseline, 12 weeks Step count measured by accelerometers
Changes in subjective appetite ratings Baseline, 12 weeks Changes in hunger, satiety, and prospective food consumption via visual analog scales
Changes in ad libitum energy intake Baseline, 12 weeks Energy intake from buffet-style meal
Changes in sedentary behavior Baseline, 12 weeks Time in sedentary activities measured by accelerometers
Trial Locations
- Locations (2)
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Univeristy of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States