Clinical trial · Interventional
Combined Modality Exercise and Appetite in Breast Cancer Survivors
Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)
NCT04576247CI-TRIAL-00058892CAREterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Overweight and Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined aerobic and resistance exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined aerobic and resistance exercise
- description
- 12 weeks of supervised resistance exercise and unsupervised aerobic exercise.
- interventionNames
- Behavioral: Combined aerobic and resistance exercise
Primary outcomes (9)
- measure
- Recruitment and enrollment feasibility
- timeFrame
- Through study completion, up to two years
- description
- Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study
- measure
- Subjective exercise adherence
- timeFrame
- Changes across weeks 4, 8, and 12
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.