Combined Modality Exercise and Appetite in Breast Cancer Survivors

NCT ID: NCT04576247

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2021-09-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Combined aerobic and resistance exercise

12 weeks of supervised resistance exercise and unsupervised aerobic exercise.

Group Type: EXPERIMENTAL

Combined aerobic and resistance exercise

Intervention Type: 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.

Interventions

Combined aerobic and resistance exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Uncontrolled hypertension defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition becomes 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Colorado Clinical & Translational Sciences Institute

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univeristy of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University of Colorado Cancer Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

19-3032.cc

Identifier Type: -

Identifier Source: org_study_id