Combined Modality Exercise and Appetite in Breast Cancer Survivors

NCT04576247 | Terminated

• 1 other identifier: 19-3032.cc
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Breast Cancer Female; Overweight and Obesity

Outcome Measures

Primary Outcomes (9)

• Recruitment and enrollment feasibility

  Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study

  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.

  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

  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

  Changes across weeks 4, 8, and 12

• Intervention acceptability

  Subjective ability to adhere to combined AEx/REx

  12 weeks

• Intervention acceptability

  Barriers to completing AEx/REx

  12 weeks

• Intervention acceptability

  Open-ended opinions on the structure and content of the exercise training sessions

  12 weeks

• Intervention acceptability

  Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention

  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

  12 weeks

Secondary Outcomes (6)

• Changes in ghrelin

  Baseline, 12 weeks

• Changes in peptide-YY (PYY)

  Baseline, 12 weeks

• Changes in subjective appetite ratings

  Baseline, 12 weeks

• Changes in ad libitum energy intake

  Baseline, 12 weeks

• Changes in physical activity

  Baseline, 12 weeks

Other Outcomes (3)

• Changes in resting energy expenditure

  Baseline, 12 weeks

• Changes in body composition

  Baseline, 12 weeks

• Changes in fatigue

  Baseline, 12 weeks

Study Arms (1)

Combined aerobic and resistance exercise

EXPERIMENTAL

12 weeks of supervised resistance exercise and unsupervised aerobic exercise.

Behavioral: Combined aerobic and resistance exercise

Interventions

Combined aerobic and resistance exercise BEHAVIORAL

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.

Combined aerobic and resistance exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Clinical & Translational Sciences Institute: collaborator
• National Cancer Institute (NCI): collaborator

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

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking is not possible because this is a single-arm exercise study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 6, 2020
• Study Start: June 5, 2020
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)