Clinical trial · Interventional
Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.
The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer: A Phase I-II Study
NCT00405678CI-TRIAL-00015064completedPhase 1 / Phase 2ClinicalTrials.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)
To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.
Conditions
Conditions (1)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemo only | Behavioral | — | UNRESOLVED |
| Exercise Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Subjects receiving chemo and exercise training
- interventionNames
- Behavioral: Exercise Training
- type
- EXPERIMENTAL
- label
- 2
- description
- Subjects receiving chemo only
- interventionNames
- Behavioral: Exercise Training
- Behavioral: Chemo only
Primary outcomes (1)
- measure
- Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed operable primary breast cancer * Age 18 or older * Karnofsky performance status greater than 70 * No previous malignancy * Absence of significant cardiac disease (left ventricular ejection fraction greater than or equal to 50%) * No hormonal replacement therapy use within the past month * Not pregnant * Ability to read and understand English * Signed written informed consent prior to beginning protocol specific procedures * Willing to travel to DUMC to exercise three times per week * Primary treating oncologist approval
References
Publications (78)
- BACKGROUNDAmerican Cancer Society (2005). Cancer: Facts and Figures. ACS, Atlanta, GA.
- BACKGROUNDCole BF, Gelber RD, Gelber S, Coates AS, Goldhirsch A. Polychemotherapy for early breast cancer: an overview of the randomised clinical trials with quality-adjusted survival analysis. Lancet. 2001 Jul 28;358(9278):277-86. doi: 10.1016/S0140-6736(01)05483-6. PMID 11498214
- BACKGROUNDCutuli B, Fourquet A, Luporsi E, Arnould L, Caron Y, Cremoux Pd, Dilhuydy JM, Fondrinier E, Fourme E, Giard-Lefevre S, Blanc-Onfroy ML, Lemanski C, Mauriac L, Sigal-Zafrani B, Tardivon A, This P, Tunon de Lara C, Kirova Y, Fabre N; Federation of French Cancer Centres (FNCLCC), et le groupe de travail SOR. [Standards, Options and Recommendations for the management of ductal carcinoma in situ of the breast (DCIS): update 2004]. Bull Cancer. 2005 Feb;92(2):155-68. French. PMID 15749645
- BACKGROUNDGoldhirsch A, Glick JH, Gelber RD, Coates AS, Senn HJ. Meeting highlights: International Consensus Panel on the Treatment of Primary Breast Cancer. Seventh International Conference on Adjuvant Therapy of Primary Breast Cancer. J Clin Oncol. 2001 Sep 15;19(18):3817-27. doi: 10.1200/JCO.2001.19.18.3817. No abstract available. PMID 11559719
- BACKGROUNDRauschecker H, Clarke M, Gatzemeier W, Recht A. Systemic therapy for treating locoregional recurrence in women with breast cancer. Cochrane Database Syst Rev. 2001;2001(4):CD002195. doi: 10.1002/14651858.CD002195. PMID 11687148
- BACKGROUNDWilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev. 2003;2003(2):CD002747. doi: 10.1002/14651858.CD002747. PMID 12804433
- BACKGROUNDCurnis F, Sacchi A, Corti A. Improving chemotherapeutic drug penetration in tumors by vascular targeting and barrier alteration. J Clin Invest. 2002 Aug;110(4):475-82. doi: 10.1172/JCI15223.