Breast Cancer FemaleCARENCT04576247
Combined Modality Exercise and Appetite in Breast Cancer Survivors
A study testing Combined aerobic and resistance exercise in people with Breast Cancer Female and Overweight and Obesity, run by University of Colorado, Denver at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Cancer Female, Overweight and Obesity
- What is being tested?
- Combined aerobic and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2020to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univeristy of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
University of Colorado Cancer Center
Denver, Colorado, 80238
About this study
Official title: Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)
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).
- Conditions
- Breast Cancer Female, Overweight and Obesity
- Being tested
- Combined aerobic and resistance exercise
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined aerobic and resistance exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined aerobic and resistance exercise | Experimental | 12 weeks of supervised resistance exercise and unsupervised aerobic exercise. Receives: Behavioral: Combined aerobic and resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and enrollment feasibility
Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study
Measured: 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.
Measured: 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
Measured: 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
Measured: Changes across weeks 4, 8, and 12
Intervention acceptability
Subjective ability to adhere to combined AEx/REx
Measured: 12 weeks
Intervention acceptability
Barriers to completing AEx/REx
Measured: 12 weeks
Intervention acceptability
Open-ended opinions on the structure and content of the exercise training sessions
Measured: 12 weeks
Intervention acceptability
Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention
Measured: 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
Measured: 12 weeks
Secondary outcomes (6)
Changes in ghrelin
Fasting ghrelin, ghrelin area under the curve in response to a control meal
Measured: Baseline, 12 weeks
Changes in peptide-YY (PYY)
Fasting PYY, PYY area under the curve in response to a control meal
Measured: Baseline, 12 weeks
Changes in subjective appetite ratings
Changes in hunger, satiety, and prospective food consumption via visual analog scales
Measured: Baseline, 12 weeks
Changes in ad libitum energy intake
Energy intake from buffet-style meal
Measured: Baseline, 12 weeks
Changes in physical activity
Step count measured by accelerometers
Measured: Baseline, 12 weeks
Changes in sedentary behavior
Time in sedentary activities measured by accelerometers
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start5 Jun 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576247
- Sponsor's protocol ID
- 19-3032.cc
- Acronym
- CARE
- Status last verified
- May 2022
- First submitted
- 15 Sep 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)
- ClinicalTrials.gov ID
- NCT04576247
- Acronym / sponsor ID
- CARE / 19-3032.cc
- Conditions
- Breast Cancer Female, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Cancer Institute (NCI)
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined aerobic and resistance exercise | Experimental | Behavioral: Combined aerobic and resistance exercise12 weeks of supervised resistance exercise and unsupervised aerobic exercise. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined aerobic and resistance exerciseThe 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. | Behavioural | Combined aerobic and resistance exercise |
Primary outcome
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
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.
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
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
Intervention acceptability
Time frame: 12 weeks
Subjective ability to adhere to combined AEx/REx
Intervention acceptability
Time frame: 12 weeks
Barriers to completing AEx/REx
Intervention acceptability
Time frame: 12 weeks
Open-ended opinions on the structure and content of the exercise training sessions
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
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
6 secondary outcomes
Changes in ghrelin
Time frame: Baseline, 12 weeks
Changes in peptide-YY (PYY)
Time frame: Baseline, 12 weeks
Changes in subjective appetite ratings
Time frame: Baseline, 12 weeks
Changes in ad libitum energy intake
Time frame: Baseline, 12 weeks
Changes in physical activity
Time frame: Baseline, 12 weeks
Changes in sedentary behavior
Time frame: Baseline, 12 weeks
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined aerobic and resistance exercise in people with Breast Cancer Female and Overweight and Obesity, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and enrollment feasibility (time frame: Through study completion, up to two years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.