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Combined Modality Exercise and Appetite in Breast Cancer Survivors (CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04576247
Recruitment Status : Terminated (Low accrual)
First Posted : October 6, 2020
Last Update Posted : June 3, 2022
Sponsor:
Collaborators:
Colorado Clinical & Translational Sciences Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Female Overweight and Obesity Behavioral: Combined aerobic and resistance exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Masking is not possible because this is a single-arm exercise study.
Primary Purpose: Other
Official Title: Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)
Actual Study Start Date : June 5, 2020
Actual Primary Completion Date : September 20, 2021
Actual Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined aerobic and resistance exercise
12 weeks of supervised resistance exercise and unsupervised aerobic exercise.
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.





Primary Outcome Measures :
  1. Recruitment and enrollment feasibility [ Time Frame: Through study completion, up to two years ]
    Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study

  2. Subjective exercise adherence [ Time Frame: 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.

  3. Exercise self efficacy [ Time Frame: 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

  4. Exercise enjoyment [ Time Frame: Changes across weeks 4, 8, and 12 ]
    Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment

  5. Intervention acceptability [ Time Frame: 12 weeks ]
    Subjective ability to adhere to combined AEx/REx

  6. Intervention acceptability [ Time Frame: 12 weeks ]
    Barriers to completing AEx/REx

  7. Intervention acceptability [ Time Frame: 12 weeks ]
    Open-ended opinions on the structure and content of the exercise training sessions

  8. Intervention acceptability [ Time Frame: 12 weeks ]
    Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention

  9. Objective exercise adherence [ Time Frame: 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 :
  1. Changes in ghrelin [ Time Frame: Baseline, 12 weeks ]
    Fasting ghrelin, ghrelin area under the curve in response to a control meal

  2. Changes in peptide-YY (PYY) [ Time Frame: Baseline, 12 weeks ]
    Fasting PYY, PYY area under the curve in response to a control meal

  3. Changes in subjective appetite ratings [ Time Frame: Baseline, 12 weeks ]
    Changes in hunger, satiety, and prospective food consumption via visual analog scales

  4. Changes in ad libitum energy intake [ Time Frame: Baseline, 12 weeks ]
    Energy intake from buffet-style meal

  5. Changes in physical activity [ Time Frame: Baseline, 12 weeks ]
    Step count measured by accelerometers

  6. Changes in sedentary behavior [ Time Frame: Baseline, 12 weeks ]
    Time in sedentary activities measured by accelerometers


Other Outcome Measures:
  1. Changes in resting energy expenditure [ Time Frame: Baseline, 12 weeks ]
    Resting energy expenditure measured by metabolic cart and adjusted for body composition changes

  2. Changes in body composition [ Time Frame: Baseline, 12 weeks ]
    Fat mass and fat-free mass in kg, measured by dual X-ray absorptiometry

  3. Changes in fatigue [ Time Frame: Baseline, 12 weeks ]
    Measured by the Functional Assessment of Chronic Illness and Therapy - Fatigue; 13 questions; score range: 0-52, with higher score indicating higher fatigue



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576247


Locations
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United States, Colorado
Univeristy of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center
Denver, Colorado, United States, 80238
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
National Cancer Institute (NCI)
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04576247    
Other Study ID Numbers: 19-3032.cc
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight