NCT04300478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2022

Completed
Last Updated

December 6, 2024

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 25, 2020

Last Update Submit

December 3, 2024

Conditions

OverweightBreast CancerObesity

Keywords

AppetiteEnergy intakeEnergy metabolismNutritionExercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Peptide-YY (PYY) area under the curve (AUC) in response to exercise or control

    2 years

  • Subjective ratings of hunger in response to exercise or control

    2 years

  • Subjective ratings of food-related cravings in response to exercise or control

    2 years

  • Subjective ratings of appeal/desire for hedonic foods in response to exercise or control

    2 years

  • Subjective ratings of satiety in response to exercise or control

    2 years

  • +5 more secondary outcomes

Other Outcomes (4)

  • Resting energy expenditure (REE)

    2 years

  • Body composition (fat mass[FM])

    2 years

  • Body composition (Fat-free mass [FFM])

    2 years

  • +1 more other outcomes

Study Arms (2)

Sedentary Control/REx

OTHER

Subjects will complete the Sedentary control testing sessions, have a 7-14 day washout period, and then complete the REx

Behavioral: REx Condition FirstBehavioral: 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

Behavioral: REx Condition FirstBehavioral: Sedentary Control Condition First

Interventions

REx Condition FirstBEHAVIORAL

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.

REx/Sedentary ControlSedentary Control/REx
Sedentary Control Condition FirstBEHAVIORAL

Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.

REx/Sedentary ControlSedentary Control/REx

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale Sex
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Univeristy of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80238, United States

Location

Related 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.

    PMID: 36539160BACKGROUND

Related Links

MeSH Terms

Conditions

OverweightBreast NeoplasmsObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Ed Melanson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 9, 2020

Study Start

February 7, 2020

Primary Completion

February 2, 2022

Study Completion

February 5, 2022

Last Updated

December 6, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)