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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01265 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.
Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.
PRIMARY OBJECTIVES:
I. To determine whether a 16-week exercise intervention will improve components of metastasis (MetS) in breast cancer survivors soon after completion of cancer-related treatments by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c (HbA1c).
II. To determine whether a 16-week exercise intervention will improve physical fitness in breast cancer survivors soon after completion of cancer-related treatments by measuring cardiorespiratory fitness and muscle strength.
III. To assesses the feasibility of a supervised exercise intervention in early breast cancer survivors.
IV. To determine whether a 16-week exercise intervention will result in a reduction in adipose tissue inflammation in obese breast cancer survivors soon after completion of cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.
V. To determine whether breast cancer survivors can maintain positive benefits of an exercise intervention following a 12-week follow-up period by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.
OUTLINE:
Patients are randomized to 1 of 2 arms.
Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.
Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Control) | Active Comparator | Patients refrain from increasing physical activity levels for 16 weeks. |
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| Arm II (Exercise) | Experimental | Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Administered within 3 days of baseline testing and at post-trial visit |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c | At week 16 | |
| Improvement of physical fitness, cardiorespiratory fitness, and muscle strength | At week 16 | |
| Feasibility of a supervised exercise program for cancer survivors | At week 16 | |
| Maintain positive benefits of an exercise intervention | 12 weeks post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, Ph.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34413391 | Derived | Dieli-Conwright CM, Sami N, Norris MK, Wan J, Kumagai H, Kim SJ, Cohen P. Effect of aerobic and resistance exercise on the mitochondrial peptide MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors. Sci Rep. 2021 Aug 19;11(1):16916. doi: 10.1038/s41598-021-96419-z. | |
| 33929533 | Derived | Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Norris MK, Fox FS, Buchanan TA, Spicer D, Bernstein L, Tripathy D. Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis. Sleep. 2021 Oct 11;44(10):zsab111. doi: 10.1093/sleep/zsab111. |
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| quality-of-life assessment | Procedure | Administered within 3 days of baseline testing and at post-trial visit |
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| management of therapy complications | Procedure | Assessed within 3 days of baseline testing and at post-trial visit |
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| exercise intervention | Behavioral | 12 week exercise intervention |
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| 33292676 | Derived | Lee K, Sami N, Tripathy D, Demark-Wahnefried W, Norris MK, Courneya KS, Dieli-Conwright CM. Aerobic and resistance exercise improves Reynolds risk score in overweight or obese breast cancer survivors. Cardiooncology. 2020 Nov 24;6(1):27. doi: 10.1186/s40959-020-00084-6. |
| 31309977 | Derived | Sweeney FC, Demark-Wahnefried W, Courneya KS, Sami N, Lee K, Tripathy D, Yamada K, Buchanan TA, Spicer DV, Bernstein L, Mortimer JE, Dieli-Conwright CM. Aerobic and Resistance Exercise Improves Shoulder Function in Women Who Are Overweight or Obese and Have Breast Cancer: A Randomized Controlled Trial. Phys Ther. 2019 Oct 28;99(10):1334-1345. doi: 10.1093/ptj/pzz096. |
| 30920602 | Derived | Lee K, Tripathy D, Demark-Wahnefried W, Courneya KS, Sami N, Bernstein L, Spicer D, Buchanan TA, Mortimer JE, Dieli-Conwright CM. Effect of Aerobic and Resistance Exercise Intervention on Cardiovascular Disease Risk in Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):710-714. doi: 10.1001/jamaoncol.2019.0038. |
| 30340503 | Derived | Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6. |
| 29356607 | Derived | Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Buchanan TA, Spicer DV, Tripathy D, Bernstein L, Mortimer JE. Effects of Aerobic and Resistance Exercise on Metabolic Syndrome, Sarcopenic Obesity, and Circulating Biomarkers in Overweight or Obese Survivors of Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Mar 20;36(9):875-883. doi: 10.1200/JCO.2017.75.7526. Epub 2018 Jan 22. |
| 24708832 | Derived | Dieli-Conwright CM, Mortimer JE, Schroeder ET, Courneya K, Demark-Wahnefried W, Buchanan TA, Tripathy D, Bernstein L. Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods. BMC Cancer. 2014 Apr 3;14:238. doi: 10.1186/1471-2407-14-238. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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