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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00070 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1B-16-11 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese.
PRIMARY OBJECTIVES:
I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on obesity-associated chronic inflammation.
SECONDARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.
TERTIARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on breast cancer prognosis and assess whether reductions in chronic inflammation are associated with breast cancer prognosis.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
GROUP II: Patients undergo supervised traditional aerobic and resistance exercise (TARE) program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
GROUP III: Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional digital video disc (DVD) and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I.
After completion of study, patients are followed up at week 34, 8 and 12 months, and then every year for 8 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (CARE program) | Experimental | Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks. |
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| Group II (TARE program) | Experimental | Patients undergo supervised TARE program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks. |
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| Group III (home-based stretching program) | Active Comparator | Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional DVD and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Undergo supervised CARE program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of adipose tissue inflammation assessed by measuring M1 and M2 adipose tissue macrophages, crown-like structures, and adipose tissue secretion levels of inflammatory cytokines secreted | Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes. Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period. Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month). The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes. | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Distant DFS defined as events that are either lethal (death from any cause) or a direct threat to patient survival (distant recurrence or second primary invasive cancer) | Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group). Ancillary analyses will assess associations of inflammation measures with DFS. Results will be presented as hazard ratios, with 95% confidence intervals. Unadjusted and adjusted survival curves will be presented by treatment group. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35795051 | Derived | Kang DW, Wilson RL, Gonzalo-Encabo P, Norris MK, Hans M, Tahbaz M, Dawson J, Nguyen D, Normann AJ, Yunker AG, Sami N, Uno H, Ligibel JA, Mittelman SD, Dieli-Conwright CM. Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors (The AIM Trial): Rationale, Design, and Methods. Front Oncol. 2022 Jun 20;12:896995. doi: 10.3389/fonc.2022.896995. eCollection 2022. |
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| Exercise Intervention |
| Behavioral |
Undergo supervised TARE program |
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| Exercise Intervention | Behavioral | Undergo home-based stretching program |
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| Informational Intervention | Other | Receive instructional DVD and booklet of the flexibility exercises |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 8 years |
| Overall survival | Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group). | From randomization to death from any cause, assessed up to 8 years |
| Recurrence-free interval defined as events directly attributable to the original breast cancer including invasive ipsilateral breast tumor recurrence; local, regional or distant recurrence; and death from breast cancer | A competing risks analysis will be conducted, with death modeled as a competing event, using the Fine-Gray proportional hazards model. Analyses will be presented unadjusted, as well as adjusted for prognostic variables (age, estrogen receptor (ER)/HER2 status, tumor size, presence/number of positive nodes, and surgery (mastectomy vs. breast-sparing). | Up to 8 years |
| Sarcopenic obesity assessed using dual energy X-ray absorptiometry | Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes. Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period. Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month). The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes. | Up to 8 months |
| From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years |
| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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