Appetite and Exercise in Breast Cancer Survivors

Breast Cancer Clinical Trial

— EARNESt  

Official title:

The Effects of Acute Resistance Exercise on Energy Balance Regulation Among Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300478
• Other study ID #: 19-1974.cc
• Secondary ID: UL1TR002535KL2TR
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: February 5, 2022

Study information

• Verified date: March 2023
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 5, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity
• Overweight

Intervention

Behavioral:
• REx Condition First
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 First
Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.

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 (4)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting energy expenditure (REE)	REE will be measured for 20-25 minutes after a period of 30 minutes of quiet rest using an indirect calorimeter with ventilated hood (Parvo Medics metabolic cart). This test measures oxygen consumed and carbon dioxide exhaled to calculate REE (in kilocalories/day) using the Weir formula.	2 years
Other	Body composition (fat mass[FM])	Data on participant's FM will be collected using a full body dual X-ray absorptiometry (DEXA; Hologic Delphi-W, Hologic Inc., Bedford, MA). The scanner will be calibrated according to the manufacturer's guidelines. All participants will undergo a pregnancy test before body composition testing. Body composition variables will be expressed in absolute terms and controlling for height (e.g. FM index: FM [kg]/height [m2])	2 years
Other	Body composition (Fat-free mass [FFM])	Data on participant's FFM will be collected using a full body dual X-ray absorptiometry (DEXA; Hologic Delphi-W, Hologic Inc., Bedford, MA). The scanner will be calibrated according to the manufacturer's guidelines. All participants will undergo a pregnancy test before body composition testing. Body composition variables will be expressed in absolute terms and controlling for height (e.g. FFM will also be expressed in relation to FM (FM:FFM).	2 years
Other	Gonadal hormones (estradiol and progesterone)	Additional blood for a single assessment of estradiol (Beckman Coulter) and progesterone (Beckman Coulter) will be collected at baseline during the first study visit to control for these hormones in the statistical analyses.	2 years
Primary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years

External Links

•   Main results of the study