Combined Modality Exercise and Appetite in Breast Cancer Survivors

Overweight and Obesity Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04576247
• Other study ID #: 19-3032.cc
• Status: Terminated
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Combined aerobic and resistance exercise
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.

Locations

Country	Name	City	State
United States	Univeristy of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Colorado Cancer Center	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado Clinical & Translational Sciences Institute, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in resting energy expenditure	Resting energy expenditure measured by metabolic cart and adjusted for body composition changes	Baseline, 12 weeks
Other	Changes in body composition	Fat mass and fat-free mass in kg, measured by dual X-ray absorptiometry	Baseline, 12 weeks
Other	Changes in fatigue	Measured by the Functional Assessment of Chronic Illness and Therapy - Fatigue; 13 questions; score range: 0-52, with higher score indicating higher fatigue	Baseline, 12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Intervention acceptability	Subjective ability to adhere to combined AEx/REx	12 weeks
Primary	Intervention acceptability	Barriers to completing AEx/REx	12 weeks
Primary	Intervention acceptability	Open-ended opinions on the structure and content of the exercise training sessions	12 weeks
Primary	Intervention acceptability	Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention	12 weeks
Primary	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	Changes in ghrelin	Fasting ghrelin, ghrelin area under the curve in response to a control meal	Baseline, 12 weeks
Secondary	Changes in peptide-YY (PYY)	Fasting PYY, PYY area under the curve in response to a control meal	Baseline, 12 weeks
Secondary	Changes in subjective appetite ratings	Changes in hunger, satiety, and prospective food consumption via visual analog scales	Baseline, 12 weeks
Secondary	Changes in ad libitum energy intake	Energy intake from buffet-style meal	Baseline, 12 weeks
Secondary	Changes in physical activity	Step count measured by accelerometers	Baseline, 12 weeks
Secondary	Changes in sedentary behavior	Time in sedentary activities measured by accelerometers	Baseline, 12 weeks