OverweightEARNEStNCT04300478
Appetite and Exercise in Breast Cancer Survivors
A study testing REx Condition First in people with Overweight and Breast Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The overall aim of this research is to investigate the acute effects of resistance exercise (REx) on the hormonal and behavioral indices of energy balance regulation in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Overweight, Breast Cancer, Obesity
- What is being tested?
- REx Condition First
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2020to 5 Feb 2022
- 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, since older age may impact appetite regulation45-47 and women >45 are more likely to have begun the menopausal transition (estrogen relates to appetite and eating behavior)
- Body mass index [BMI]: 25 - 35 kg/m2. Since body composition and body mass relate to appetite regulation and energy intake, a narrow BMI range should decrease heterogeneity within the results. The BMI range was chosen to represent a population at risk for developing obesity and associated comorbidities, while also excluding individuals with severe obesity (which may plausibly significantly impact energy intake regulation).
- Pre-menopausal before cancer diagnosis and treatment
- <1 hour/week of planned physical activity by self-report in the previous 12 months, since exercise may alter appetite and response to food
- Diagnosis of primary stage I - II 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
- Cancer diagnosis in the last 5 years before breast cancer; any site, excluding melanoma
- History of cardiovascular disease or symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, syncope
- Diabetes mellitus, uncontrolled hypertension (defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit with participants seated quietly), untreated/uncontrolled thyroid disease, or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition become 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 metabolism, EI or energy expenditure in the last 3 months (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
Show all 15Show fewer
- 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 use
- 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 (CTRC) 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, Dr. Marc-Andre Cornier).
- 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: The Effects of Acute Resistance Exercise on Energy Balance Regulation Among Breast Cancer Survivors
The overall aim of this research is to investigate the acute effects of resistance exercise (REx) on the hormonal and behavioral indices of energy balance regulation in breast cancer survivors. This pilot study is designed to provide preliminary data to support future exercise interventions with more comprehensive energy balance profiling.
Read the detailed description
After screening, eligible and consented participants will complete baseline evaluations of REE, body composition, and subjective questionnaires to assess energy balance. Eligible and interested individuals will attend an exercise familiarization session in the two weeks before the initial study visit. Individuals will then be randomized to either sedentary control/REx or REx/sedentary control in a 1:1. A washout period of approximately 7-14 days will separate testing sessions.
A randomized cross-over short-term study design was chosen to assessment to profile appetite, energy intake, and physical activity in controlled and free-living settings while also reducing participant burden (as opposed to a long-term intervention). Participants will serve as their own controls, thereby circumventing inter-individual variation in physiology that may confound results. It is anticipated that responses to acute exercise will be amplified in chronic interventions and may therefore be used as a basis for generating hypotheses on the regulation of certain energy balance components. The study will end after the completion of 3 days of dietary intake recall and physical activity measurement for the last participant.
- Conditions
- Overweight, Breast Cancer, Obesity
- Being tested
- REx Condition First, Sedentary Control Condition First
- Keywords
- Appetite, Energy intake, Energy metabolism, Nutrition, Exercise
- Medical subject headings
- Overweight, Breast Neoplasms, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REx Condition FirstBehavioural
REx condition: Participants will complete a whole-body REx workout consisting of 1-set to failure (e.g. RPE of 9-10 on 10-point scale on final reps) on 12 exercises in the Exercise Research Laboratory (located in the CTRC), with a 3-minute rest between exercises. Participants will complete the following exercises: leg press; leg extension; leg curl; hip abduction; hip adduction; chest press; overhead press; seated row; overheard pulldowns and assisted triceps dips on Cybex resistance equipment; barbell calf raises on a Smith machine; and dumbbell biceps curls. Resistance for the REx trial will be determined based on the exercise familiarization session. Specifically, we will target a resistance level needed for each participant to complete ~12-15 repetitions per exercise, using proper form, with an RPE of 9-10 on a 10-point scale on final reps. This protocol eliminates the need for max testing in order to set an exercise protocol off of a specific intensity based on % of 1RM.
Sedentary Control Condition FirstBehavioural
Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Control/REx | Other | Subjects will complete the Sedentary control testing sessions, have a 7-14 day washout period, and then complete the REx Receives: Behavioral: REx Condition First; Behavioral: Sedentary Control Condition First |
| REx/Sedentary Control | Other | Subjects will complete the REx testing sessions, have a 7-14 day washout period, and then complete the Sedentary control Receives: Behavioral: REx Condition First; Behavioral: Sedentary Control Condition First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin area under the curve (AUC) in response to exercise or control
Ghrelin will be collected through serial IV collection. Each serum sample will be stored at -80C until analysis Radioimmunoassays will be used to determine serum total ghrelin (Milliipore). Total AUC will be calculated with the Trapezoid method, using all time points over the three hours following the control meal.
Measured: 2 years
Secondary outcomes (10)
Peptide-YY (PYY) area under the curve (AUC) in response to exercise or control
PYY will be collected through serial IV collection. Each serum sample will be stored at -80C until analysis Radioimmunoassays will be used to determine PYY (Millipore). Total AUC will be calculated with the Trapezoid method58, using all time points over the three hours following the control meal.
Measured: 2 years
Subjective ratings of hunger in response to exercise or control
Appetite Ratings will be completed using 100 mm visual analogue scale (VAS) questions (hunger, fullness, and desire to eat) at time points described above. Total AUC will be calculated using the Trapezoid method.
Measured: 2 years
Subjective ratings of food-related cravings in response to exercise or control
Subjects will rate 'food appeal', 'food pleasantness', and 'desire to eat' of validated hedonic and non-hedonic food items using the ImageRate software with 0-100mm VAS scales.
Measured: 2 years
Subjective ratings of appeal/desire for hedonic foods in response to exercise or control
Subjects will rate 'food appeal', 'food pleasantness', and 'desire to eat' of validated hedonic and non-hedonic food items using the ImageRate software with 0-100mm VAS scales.
Measured: 2 years
Subjective ratings of satiety in response to exercise or control
Appetite Ratings will be completed using 100 mm visual analogue scale (VAS) questions (hunger, fullness, and desire to eat) at time points described above. Total AUC will be calculated using the Trapezoid method.
Measured: 2 years
Ad libitum absolute and relative energy intake (EI)
Acute ad libitum EI will be measured during the buffet lunch via the weight and measure method by the dietary staff at the CTRC to measure energy and macronutrient intake following the REx and control conditions. The buffet lunch will consist of 15% more food than predicted requirements and the option to get more food as desired.
Measured: 2 years
Free-living energy intake (EI) for three days following each study day
Acute ad libitum EI will be measured during the buffet lunch via the weight and measure method by the dietary staff at the CTRC to measure energy and macronutrient intake following the REx and control conditions. The buffet lunch will consist of 15% more food than predicted requirements and the option to get more food as desired.
Measured: 2 years
Free-living physical activity for three days following each study day
Activity and sedentary behaviors will be measured with ActivPAL accelerometers for 3 days after each study visit
Measured: 2 years
Total step count for three days following each study day
Activity and sedentary behaviors will be measured with ActivPAL accelerometers for 3 days after each study visit
Measured: 2 years
Sedentary time for three days following each study day
Activity and sedentary behaviors will be measured with ActivPAL accelerometers for 3 days after each study visit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start7 Feb 2020
- Primary completion2 Feb 2022
- Study completion5 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Individuals will be randomized to either sedentary control/REx or REx/sedentary control in a 1:1 manner using online software (http://www.randomization.com).
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ed Melanson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300478
- Sponsor's protocol ID
- 19-1974.cc
- Other IDs
- UL1TR002535, KL2TR002534, TL1TR002533, P30CA046934
- Acronym
- EARNESt
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Purcell SA, Melanson EL, Afghahi A, Borges VF, Sinelli I, Cornier MA. The effects of resistance exercise on appetite sensations, appetite related hormones and energy intake in hormone receptor-positive breast cancer survivors. Appetite. 2023 Mar 1;182:106426. doi: 10.1016/j.appet.2022.106426. Epub 2022 Dec 17.
PubMed 36539160
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Resistance Exercise on Energy Balance Regulation Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04300478
- Acronym / sponsor ID
- EARNESt / 19-1974.cc
- Conditions
- Overweight, Breast Cancer, Obesity
- Keywords
- Appetite, Energy intake, Energy metabolism, Nutrition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI)
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 9 Mar 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 investigate the acute effects of resistance exercise (REx) on the hormonal and behavioral indices of energy balance regulation in breast cancer survivors. This pilot study is designed to provide preliminary data to support future exercise interventions with more comprehensive energy balance profiling.
Detailed description
After screening, eligible and consented participants will complete baseline evaluations of REE, body composition, and subjective questionnaires to assess energy balance. Eligible and interested individuals will attend an exercise familiarization session in the two weeks before the initial study visit. Individuals will then be randomized to either sedentary control/REx or REx/sedentary control in a 1:1. A washout period of approximately 7-14 days will separate testing sessions.
A randomized cross-over short-term study design was chosen to assessment to profile appetite, energy intake, and physical activity in controlled and free-living settings while also reducing participant burden (as opposed to a long-term intervention). Participants will serve as their own controls, thereby circumventing inter-individual variation in physiology that may confound results. It is anticipated that responses to acute exercise will be amplified in chronic interventions and may therefore be used as a basis for generating hypotheses on the regulation of certain energy balance components. The study will end after the completion of 3 days of dietary intake recall and physical activity measurement for the last participant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals will be randomized to either sedentary control/REx or REx/sedentary control in a 1:1 manner using online software (http://www.randomization.com).
| Arm | Type | Receives |
|---|---|---|
| Sedentary Control/REx | Other | Behavioral: REx Condition First, Behavioral: Sedentary Control Condition FirstSubjects will complete the Sedentary control testing sessions, have a 7-14 day washout period, and then complete the REx |
| REx/Sedentary Control | Other | Behavioral: REx Condition First, Behavioral: Sedentary Control Condition FirstSubjects will complete the REx testing sessions, have a 7-14 day washout period, and then complete the Sedentary control |
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, since older age may impact appetite regulation45-47 and women >45 are more likely to have begun the menopausal transition (estrogen relates to appetite and eating behavior)
- Body mass index [BMI]: 25 - 35 kg/m2. Since body composition and body mass relate to appetite regulation and energy intake, a narrow BMI range should decrease heterogeneity within the results. The BMI range was chosen to represent a population at risk for developing obesity and associated comorbidities, while also excluding individuals with severe obesity (which may plausibly significantly impact energy intake regulation).
- Pre-menopausal before cancer diagnosis and treatment
- <1 hour/week of planned physical activity by self-report in the previous 12 months, since exercise may alter appetite and response to food
Key exclusion criteria (15 listed)
- Cancer diagnosis in the last 5 years before breast cancer; any site, excluding melanoma
- History of cardiovascular disease or symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, syncope
- Diabetes mellitus, uncontrolled hypertension (defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit with participants seated quietly), untreated/uncontrolled thyroid disease, or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition become 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.
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 |
|---|---|---|
| REx Condition FirstREx condition: Participants will complete a whole-body REx workout consisting of 1-set to failure (e.g. RPE of 9-10 on 10-point scale on final reps) on 12 exercises in the Exercise Research Laboratory (located in the CTRC), with a 3-minute rest between exercises. Participants will complete the following exercises: leg press; leg extension; leg curl; hip abduction; hip adduction; chest press; overhead press; seated row; overheard pulldowns and assisted triceps dips on Cybex resistance equipment; barbell calf raises on a Smith machine; and dumbbell biceps curls. Resistance for the REx trial will be determined based on the exercise familiarization session. Specifically, we will target a resistance level needed for each participant to complete ~12-15 repetitions per exercise, using proper form, with an RPE of 9-10 on a 10-point scale on final reps. This protocol eliminates the need for max testing in order to set an exercise protocol off of a specific intensity based on % of 1RM. | Behavioural | REx/Sedentary Control, Sedentary Control/REx |
| Sedentary Control Condition FirstSedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition. | Behavioural | REx/Sedentary Control, Sedentary Control/REx |
Primary outcome
Ghrelin area under the curve (AUC) in response to exercise or control
Time frame: 2 years
Ghrelin will be collected through serial IV collection. Each serum sample will be stored at -80C until analysis Radioimmunoassays will be used to determine serum total ghrelin (Milliipore). Total AUC will be calculated with the Trapezoid method, using all time points over the three hours following the control meal.
10 secondary outcomes
Peptide-YY (PYY) area under the curve (AUC) in response to exercise or control
Time frame: 2 years
Subjective ratings of hunger in response to exercise or control
Time frame: 2 years
Subjective ratings of food-related cravings in response to exercise or control
Time frame: 2 years
Subjective ratings of appeal/desire for hedonic foods in response to exercise or control
Time frame: 2 years
Subjective ratings of satiety in response to exercise or control
Time frame: 2 years
Ad libitum absolute and relative energy intake (EI)
Time frame: 2 years
Free-living energy intake (EI) for three days following each study day
Time frame: 2 years
Free-living physical activity for three days following each study day
Time frame: 2 years
Total step count for three days following each study day
Time frame: 2 years
Sedentary time for three days following each study day
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 36539160Purcell SA, Melanson EL, Afghahi A, Borges VF, Sinelli I, Cornier MA. The effects of resistance exercise on appetite sensations, appetite related hormones and energy intake in hormone receptor-positive breast cancer survivors. Appetite. 2023 Mar 1;182:106426. doi: 10.1016/j.appet.2022.106426. Epub 2022 Dec 17.
- Main results of the studyLink provided by the sponsor.
- 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.
Ed Melanson, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REx Condition First in people with Overweight and Breast Cancer, 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 15 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: finished, as of the sponsor's last update on 6 Dec 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ghrelin area under the curve (AUC) in response to exercise or control (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300478, which also lists 1 linked publication.
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 6 Dec 2024.