Clinical trial · Interventional
Exercise Program for Early Breast Cancer Survivors
Combined Exercise Program for Early Breast Cancer Survivors
NCT01140282CI-TRIAL-00039118completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exercise intervention | Behavioral | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (Control)
- description
- Patients refrain from increasing physical activity levels for 16 weeks.
- interventionNames
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Procedure: management of therapy complications
- type
- EXPERIMENTAL
- label
- Arm II (Exercise)
- description
- 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.
- interventionNames
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Procedure: management of therapy complications
- Behavioral: exercise intervention
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed (I-III) with a first primary invasive breast cancer * Have undergone a lumpectomy or mastectomy * Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program (if randomized to that arm) within 12 weeks of therapy completion * Body mass index (BMI) \> 25 kg/m\^2 or body fat \> 30% (determined by Dr. Dieli-Conwright at baseline visit) * Currently participate in less than 60 minutes of physical activity per week May use adjuvant endocrine therapy if use will be continued for duration of study period * Nonsmokers (i.e., not smoking during previous 12 months) * Willing to travel to the exercise facility and USC * Able to provide physician clearance to participate in exercise program * Women of all racial and ethnic backgrounds will be included in the study enrollment process Exclusion Criteria: * History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease * Weight reduction \>= 10% within past 6 months * Diagnosed with human epidermal growth factor receptor 2 (HER2)-positive tumor (exclusion due to patient use of Herceptin medication for 1 year following chemotherapy) * Metastatic disease * Planned reconstructive surgery with flap repair during trial and follow-up period * Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
References
Publications (8)
- DERIVEDDieli-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. PMID 34413391
- DERIVEDDieli-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. PMID 33929533
- DERIVEDLee 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. PMID 33292676
- DERIVEDSweeney 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. PMID 31309977
- DERIVEDLee 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. PMID 30920602
- DERIVEDDieli-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.