Clinical trial NCT04300478: Appetite and Exercise in Breast Cancer Survivors
Official title: The Effects of Acute Resistance Exercise on Energy Balance Regulation Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Breast Cancer
Obesity
Keywords: Appetite
Energy intake
Energy metabolism
Nutrition
Exercise
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
name: National Center for Advancing Translational Sciences (NCATS)
name: National Cancer Institute (NCI)
First posted: 2020-03-09
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ghrelin area under the curve (AUC) in response to exercise or control
timeFrame: 2 years
Secondary outcomes:
measure: Peptide-YY (PYY) area under the curve (AUC) in response to exercise or control
timeFrame: 2 years
measure: Subjective ratings of hunger in response to exercise or control
timeFrame: 2 years
measure: Subjective ratings of food-related cravings in response to exercise or control
timeFrame: 2 years
measure: Subjective ratings of appeal/desire for hedonic foods in response to exercise or control
timeFrame: 2 years
measure: Subjective ratings of satiety in response to exercise or control
timeFrame: 2 years
measure: Ad libitum absolute and relative energy intake (EI)
timeFrame: 2 years
measure: Free-living energy intake (EI) for three days following each study day
timeFrame: 2 years
measure: Free-living physical activity for three days following each study day
timeFrame: 2 years
measure: Total step count for three days following each study day
timeFrame: 2 years
measure: Sedentary time for three days following each study day
timeFrame: 2 years
Other outcomes:
measure: Resting energy expenditure (REE)
timeFrame: 2 years
measure: Body composition (fat mass[FM])
timeFrame: 2 years
measure: Body composition (Fat-free mass [FFM])
timeFrame: 2 years
measure: Gonadal hormones (estradiol and progesterone)
timeFrame: 2 years
Locations:
city: Aurora
country: United States
facility: Univeristy of Colorado Anschutz Medical Campus
state: Colorado
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Ed Melanson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.