Clinical trial NCT04576247: Combined Modality Exercise and Appetite in Breast Cancer Survivors
Official title: Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer Female
Overweight and Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
name: National Cancer Institute (NCI)
First posted: 2020-10-06
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and enrollment feasibility
timeFrame: Through study completion, up to two years
measure: Subjective exercise adherence
timeFrame: Changes across weeks 4, 8, and 12
measure: Exercise self efficacy
timeFrame: Changes across weeks 4, 8, and 12
measure: Exercise enjoyment
timeFrame: Changes across weeks 4, 8, and 12
measure: Intervention acceptability
timeFrame: 12 weeks
measure: Intervention acceptability
timeFrame: 12 weeks
measure: Intervention acceptability
timeFrame: 12 weeks
measure: Intervention acceptability
timeFrame: 12 weeks
measure: Objective exercise adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in ghrelin
timeFrame: Baseline, 12 weeks
measure: Changes in peptide-YY (PYY)
timeFrame: Baseline, 12 weeks
measure: Changes in subjective appetite ratings
timeFrame: Baseline, 12 weeks
measure: Changes in ad libitum energy intake
timeFrame: Baseline, 12 weeks
measure: Changes in physical activity
timeFrame: Baseline, 12 weeks
measure: Changes in sedentary behavior
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Changes in resting energy expenditure
timeFrame: Baseline, 12 weeks
measure: Changes in body composition
timeFrame: Baseline, 12 weeks
measure: Changes in fatigue
timeFrame: Baseline, 12 weeks
Locations:
city: Aurora
country: United States
facility: Univeristy of Colorado Anschutz Medical Campus
state: Colorado
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
Study officials:
References: